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- 2026-03-11 21:57:56
- Policy
- Pfizer conducts trial for its RSV drug sisunatovir in KOR
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Pfizer will be conducting a clinical trial for its Respiratory Syncytial Virus (RSV) treatment PF-07923568 (sisunatovir) on infants and children in Korea. On the 7th, the Ministry of Food and Drug Safety approved Pfizer Korea's ‘Interventional, phase 1B, randomized, double-blinded, sponsor-open, placebo-controlled, multicenter, dose-finding study to evaluate the safety, tolerability, and pharmacokinetics of sisunatovir in pediatric participants up to 60 months of age with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).’ The study will be conducted at Seoul National University Bundang Hospital, Severance Hospital, Seoul National University Hospital, and Korea University Anam Hospital. As a type of common cold, RSV is an acute respiratory infection caused by the infection of the respiratory syncytial virus. It is highly contagious, affecting nearly all children by the age of 2. Most children and adults recover within a week or two without treatment, but it requires attention as it can progress to severe cases in high-risk groups such as infants, those immunocompromised, and the elderly. According to the U.S. Centers for Disease Control and Prevention, RSV causes up to 120,000 hospitalizations and up to 10,000 deaths in the U.S. each year among those aged 65 and older. Currently, AstraZeneca's ‘Synagis’ is the only licensed antibody preventive treatment for RSV that can be administered to pediatric patients. Pfizer acquired sisunatovir, a novel candidate substance for RSV when it acquired the UK-based antiviral drug developer ReViral last year. Pfizer paid up to $525 million to ReViral, including an upfront payment and future development milestone payments. Pfizer expects ReViral’s programs to generate annual sales of $1.5 billion or more. Meanwhile, other large multinational pharmaceutical companies have also jumped into the RSV prophylaxis game, and are making tangible results. Just this year, the US FDA approved GSK’s ‘Arexvy,’ Pfizer’s ‘Abrysvo,’ and AstraZeneca and Sanofi’s pediatric RSV treatment ‘Beyfortus.’ In Korea, companies such as SK Bioscience and EUGiologics have been working to develop RSV vaccines.
- Policy
- First Depakote generic is being reviewed for reimb in KOR
- by Lee, Tak-Sun Dec 08, 2023 05:55am
- The first generic of Abbot Korea’s epilepsy drug ‘Depakote ER Tab’ is undergoing a reimbursement process in Korea. The drug is ‘Divalpro ER Tab 500mg,’ developed by Korea Pharma. The drug was first approved in Korea on November 8th. It is the first generic drug to contain divalproex sodium, the main active ingredient of Depakote ER. Depakote ER was approved in Korea in 2002. It was approved in two dosage forms, and the drug posted sales of KRW 10 billion in 2022 according to IQVIA. With no patents listed on the MFDS’s green list, there were no obstacles to the approval or release of its generic versions. However, due to difficulties in bioequivalence testing, only a few companies, including Korea Pharma, WhanIn Pharma, and Mirae Pharm, had been reportedly developing its generics. In the field, Korea Pharma became the first to receive marketing authorization and seize the first generic status in Korea, making a head start in the development race. The company applied for reimbursement immediately after receiving approval. As a result, HIRA has been reviewing whether Korea Pharma’s generic drug satisfies the reimbursement conditions as part of its drug pricing calculation process. The insurance ceiling price of the original drug, Depakote ER 500mg, is currently KRW 391. If Divalpro ER satisfies both requirements – directly completing bioequivalence tests and using a substance registered in the DMF – its price will be set at 53.55% of the price the original drug received before patent expiry. In Korea, generic drugs usually take 3 months from reimbursement to listing, so it is expected that the drug will be listed for reimbursement in February next year, after which the company will conduct full-scale marketing activities. The introduction of reimbursed generics means that the prescribing options will be expanded in the field. The drug is indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures.
- Policy
- HIRA’s reimb reevaluation results to be released on the 7th
- by Lee, Tak-Sun Dec 07, 2023 05:47am
- The final results of the 2023 reimbursement adequacy reevaluations will be released on the 7th. On the day, the Health Insurance Review and Assessment Service’s Drug Reimbursement Evolution Committee will deliberate on the final reevaluation results that reflect the appeals made by pharmaceutical companies on the first results. In general, the pharmaceutical industry is not expecting the results to differ greatly from the first results, given the lack of appeals that were filed. However, in the case of hyaluronic acid eye drops, the committee discussed revising the reimbursement standards regarding the use amount after releasing the initial results, so industry eyes are on whether DREC will make a final decision on this on the 7th. The initial results announced at the end of DREC’s September 6 meeting concluded that rebamipid and levosulfiride were reimbursable. However, limaprostalpha-dex for improving ischemic symptoms of Berger's disease, such as ulcers, arterial pain, and coldness, was not considered to be adequate for reimbursement. Also, loxoprofen’s use to reduce fever and pain related to acute upper respiratory tract infection was not considered to be adequate for reimbursement. In the case of hyaluronic acid eye drops, which attracted the most attention, the committee deemed reimbursement inadequate for its use for exogenous diseases caused by surgery, drugs, trauma, or contact lens wear. Although its use for endogenous diseases such as Sjögren's syndrome, mucocutaneous ocular syndrome, and dry eye syndrome were deemed adequate, the committee determined that its reimbursement standards such as the number of prescriptions per patient visit and the total number of prescriptions per patient per year would need to be established for its appropriate use. The industry generally expressed pleasure about the initial results because the indications that were deemed non-reimbursable were not the drugs’ primary indications. However, as antipyretic and analgesic indications for loxoprofen have been heavily used during the COVID-19 pandemic, there was some pushback regarding its non-reimbursement in the medical community. In the case of the hyaluronic acid eye drops, there were fewer appeals from pharmaceutical companies because s its use for exogenous diseases is relatively low. The approved use for endogenous diseases accounts for the absolute majority of hyaluronic acid eye drop prescriptions, with over an 80% share. However, the industry is keeping a keen eye on restrictions that may be made on its use volume. Although there has been an opinion that its annual use should be restricted to 60 eyedrops (4 boxes), it has been reported that the committee had difficulty coming up with a unified plan due to strong opposition from the medical community and the pharmaceutical industry. Nevertheless, the industry prospects are that HIRA will report the results of its discussion to DREC to make a final decision. However, it is unlikely that DREC will come to an easy conclusion, therefore the reimbursement standards for restricting the volume is likely to be discussed beyond the year, according to industry analysis. If revisions to the reimbursement standards are postponed for this reason, it is expected that sodium hyaluronate eye drops’ reimbursement standards for exogenous diseases will first be removed and be granted reimbursement use only for endogenous diseases from January next year. An industry official said, "In the case of sodium hyaluronate eye drops, restricting its usage may greatly affect performance. We are waiting to see what decision DREC will make on this tomorrow."
- Policy
- Bill proposed to prioritize domestic drugs and vaccines
- by Lee, Jeong-Hwan Dec 06, 2023 06:00am
- A bill has been presented to prioritize purchases and use of domestic drugs and vaccines when Korea's national and local governments conduct drug stockpiling and National Immunization Programs (NIP). The bill also contains a provision to strengthen Korea's pharmaceutical sovereignty, including a plan to promote self-sufficiency of drugs in the Comprehensive Plan for Pharmaceutical Industry Development and Support. On April 24, Rep. Young-hee Choi, a member of the People Power Party presented a bill as representative to partially amend the Special Act on Fostering and Supporting the Pharmaceutical Industry. The current law requires the Minister of Health and Welfare to establish a Comprehensive Plan for Pharmaceutical Industry Development and Support every 5 years, which includes mid-to-long-term goals for fostering the pharmaceutical industry, to create a basis for industry development and strengthen its international competitiveness. However, the need to strengthen Korea’s drug sovereignty to enable domestic companies to develop and produce vaccines and essential medicines independently to overcome public health crises such as COVID-19 has been constantly raised since the COVID-19 outbreak. As competition among countries to foster the pharmaceutical industry is intensifying, the argument is that Korea also needs a policy to firmly establish its pharmaceutical sovereignty and rise to become a pharmaceutical powerhouse. For this, the revision presented by Rep. Choi includes amendments to provide grounds for the national government and local governments to prioritize the purchase of domestically produced drugs when conducting drug stockpiling or for Korea’s National Immunization Program (NIP), and to include a plan that can promote self-sufficiency of drugs in the contents of the Comprehensive Plan for Pharmaceutical Industry Development and Support. Rep. Choi said, "The Yoon Suk-yeol government has set the goal of making Korea one of the Top 6 global pharmaceutical and bio-pharma powerhouses by 2027. In the post-COVID-19 era, where the world is pursuing a “My nation first” policy for medicines, we hope that Korea will be able to achieve pharmaceutical sovereignty and emerge as a pharmaceutical and bio-pharma powerhouse by increasing the self-sufficiency rate of medicines.”
- Policy
- New price adj guidelines set for drugs with unstable supply
- by Lee, Tak-Sun Dec 06, 2023 06:00am
- On the 5th, the National Health Insurance Service established the ‘Pricing adjustment negotiation guidelines for insurance ceiling price of drugs.’ The guideline gained attention for specifying the negotiation content for drugs that have an unstable supply. The guideline also includes the submission of pre-negotiation materials for drugs with unstable supply and premium pricing measures. The NHIS explained that the purpose of the Pricing adjustment negotiation guidelines is to stabilize the supply and demand of drugs that are essential for patient care but do not have smooth supply due to low profitability. The pricing adjustment negotiations are conducted for drugs that have received a negotiation order from the Ministry of Health and Welfare as deemed necessary based on the NHIS Drug Reimbursement Evaluation Committee’s evaluation results of submitted pricing adjustment applications. After receiving the negotiation order, subject companies need to submit evidence of drug cost for the drug subject to negotiation and data on the contract production (import) volume that would be produced (imported) after adjusting the upper price limit. The new guideline requires drugs that need prior discussion to speed up the negotiation period by submitting the abovementioned data prior to negotiations. Therefore, if the MOHW requests prior consultation, the company is required to submit evidence of drug cost for the drug subject to negotiation and data on the contract production (import) volume that would be produced (imported) after adjusting the upper price limit. In addition, if there is an urgent request from the public-private consultative body on the need for a specific drug with unstable supply, the estimated contract production (import) volume data after adjusting the upper price limit must be submitted within 5 days of request. The guidelines set for drugs with unstable supply and demand show the government’s plan to first discuss the contracted production volume amount that will be produced after pricing adjustments to speed up production. Also, drugs with unstable supply and demand will be granted a premium when raising the upper price limit. One percent of the price will be additionally raised if the drug satisfies 1 of the 10 items in the list of policy-related premium pricing conditions, which include cases evaluated as ‘exceptional cases such as infectious disease crises or urgent supply shortages, for which central administrative agencies request cooperation related to drug supply.’ In other words, pricing adjustments requested by the public-private consultative body for drugs with unstable supply and demand will be granted a premium. However, the policy-added benefit is not to exceed a maximum of 7%. The guideline also specified a follow-up plan conditional on production expansion. The NHIS and the company can contract a certain amount of mandatory production (import) volume as needed for a certain period of time, which the company must produce (import) and supply faithfully according to the contract. It also prohibits companies from applying pricing adjustments again for 3 years after receiving pricing adjustments but leaves the door open for cases of medical necessity for the public, such as the spread of infectious diseases. Specifically, negotiations and pricing readjustments are allowed for drugs deemed necessary by the Drug Reimbursement Evaluation Committee. According to the formula, only up to 22% of Selling, General and Administrative Expenses (SGA) will be recognized, and non-operating profits and losses will not be recognized. In addition, a maximum of 17% of the total cost is recognized as reasonable profit, and the distribution margin of 3.44% will be applied to high-priced drugs and 5.15% to low-priced drugs. Hae-Min Jung, Deputy Minister of NHIS Pharmaceutical Management Department, said, “We created the new guideline because it took a long time for pharmaceutical companies to prepare data required for the previous adjustment negotiations, and issues such as sales and administrative costs had hindered prompt negotiations. The NHIS will conduct prompt negotiations per the new guidelines and actively sign and manage supply volume contracts to ensure that essential drugs are supplied to the front line." Meanwhile, the government is actively reviewing drug price increases for drugs with unstable supply and demand and is considering including them eligible for adjustment applications. In line with the government's policy, the guidelines for pricing adjustment negotiations also include exceptional negotiation clauses for drugs with unstable supply and demand. Only this year, prices of magnesium hydroxide, pseudoephedrine budesonide, suspension for nebulizer were granted price hikes through pricing adjustment negotiations, and acetaminophen fever reducer syrups and cefditoren pivoxil Fine Granule and constipation treatments that contain lactulose are being reviewed for pricing adjustments.
- Policy
- MOHW will expand drugs subject to price adjustments
- by Lee, Tak-Sun Dec 05, 2023 05:48am
- To ensure higher drug prices for medicines in short supply, the Ministry of Health and Welfare (MOHW) announced its plan to revise the evaluation standard for drugs eligible to apply for pricing adjustments to increase the upper limit price (list price). Accordingly, national essential drugs and those selected by public-private consultative bodies as having unstable supply will be eligible to apply for price increase adjustments. According to industry sources on December 4th, the MOHW is reviewing a plan to include national essential drugs and drugs suggested to be in short supply by its public-private consultative body as subjects in its evaluation standard to adjust the upper limit price. The current evaluation standard allows drug pricing adjustments to be made for drugs ▲with no alternative drugs are available; ▲absolutely necessary for treatment; ▲necessary for treatment, and the cost of medication is cheaper than its alternative but the administration and ingredients are the same, and there is only 1 manufacturer produces the drug. A drug essential for treatment should meet the following criteria, ▲have no available alternative therapies (including medicines) ▲is used for serious diseases with low survival rates ▲is used for rare diseases that affect a small group of patients ▲has demonstrated clinically significant improvement such as a substantial extension of survival time, and other cases where the committee evaluates it absolutely necessary for the patient’s treatment. The drugs that have recently had supply shortages and raised concern in pharmacies, often do not meet the current evaluation criteria. To resolve the current issue, the government is considering revising the evaluation criteria to include national essential drugs and drugs deemed necessary for price increase by the public-private consultative body to resolve the supply instability issue. The Ministry of Food and Drug Safety recently added 6 types of 7 pediatric medicines, including acetaminophen syrup and tulobuterol transdermal patches to the list of national essential drugs. The industry views this as a step towards adding the qualification for drug price increase adjustment requests for national essential drugs. The industry views the proposed revision is a measure to quell potential disputes over criteria that may arise in the future, as the government is considering the drug price increase as part of measures to address the supply shortage of particular drugs. Consequently, there is speculation that drugs that do not qualify for adjustment requests will still go through the price increase process, with their legitimacy being granted through subsequent revisions of the criteria. On December 7th, HIRA's Drug Reimbursement Evaluation Committee will review pricing adjustment requests for 5 pharmaceutical products that have supply shortages. The candidate products include Sama Pharm's 'Setophen Suspension', Johnson & Johnson Korea’s 'Children's Tylenol Suspension', Boryung's ' Meiact Fine Granule Boryung', Kukje Pharm's 'Ditoren Fine Granules', and JW Pharmaceutical's 'Dulackhan Easy Syrup', among others.
- Policy
- Tagrisso and Leclaza complete drug pricing negotiations
- by Lee, Tak-Sun Dec 04, 2023 05:13am
- The National Health Insurance Serivce was found to have completed pricing negotiations with the companies for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as first-line treatments for non-small cell lung cancer through the risk-sharing agreement (RSA) system. However, as the two were applied different types of RSA, the actual reimbursed prices of the two drugs are expected to differ somewhat. According to industry sources on the 1st, AstraZeneca, which owns Tagrisso, and Yuhan Corp, which owns Leclaza, recently completed drug price negotiations with the NHIS. The pricing negotiations had been ongoing with the NHIS since late September for Tagrisso, and since late October for Leclaza, but the authorities had reportedly treated the two drugs as a single set for reimbursement deliberations. Yuhan Corp has been providing Leclaza as a first-line treatment to patients free of charge through an Early Access Program (EAP) until its reimbursement, without limiting the number of patients. This was why the initial treatment refund type RSA was not applied during its pricing negotiations., Initial treatment refund-type RSA is a risk-sharing approach that takes into account uncertainties such as the effectiveness of the drug during the initial treatment period. Instead, Leclaza was applied 2 types of RSA during negotiations – Refund type and Expenditure Cap type RSA. On the other hand, Tagrisso was applied initial treatment refund type, refund type, and expenditure cap type RSA. Due to differences in the type of RSA applied, the NHIS seemingly has balanced the prices of the two drugs by setting different refund rates. As such, the refund rate for Leclaza, which was not applied the initial treatment refund-type RSA, will be higher than that of Tagrisso. As such, the actual price of Leclaza is also likely to be somewhat lower than that of Tagrisso The list price is also expected to decrease slightly with the increase in the reimbursement rate. Currently, the insurance price ceiling (list price) is set at KRW 68,964 per tablet for Leclaza, while Tagrisso (80 mg) is set at KRW 212,148 per tablet. As Leclaza is taken three times a day, and Tagrisso once a day, the total drug cost is slightly cheaper for Leclaza. However, depending on the refund rate, the actual difference in price may increase further.
- Policy
- Preferential pricing plan will be further discussed by HIPDC
- by Lee, Tak-Sun Dec 04, 2023 05:12am
- The government’s announcement of the plan to improve Korea’s drug pricing system to properly compensate for the innovation value of new drugs (hereinafter referred to as the New Drug Preference Pricing Plan) is expected to be made around the end of this month. The plan was originally set to be presented for deliberation at the general meeting of the Health Insurance Policy Deliberation Committee (HIPDC) on the 8th of this month, but the Health Insurance Policy Deliberation Subcommittee decided that the agenda requires further discussion. According to the industry on the 3rd, the New drug preference pricing plan had been presented as an agenda for deliberation on the 22nd, but the subcommittee decided to continue further discussions. As such, another subcommittee meeting is expected to be held around the middle of this month. Prior to this, the contents of the New drug preference pricing plan will be shared at a meeting with the pharmaceutical industry. This is also expected to be held in the middle of this month, ahead of the subcommittee meeting. The New drug preference pricing plan has been discussed with the pharmaceutical industry since January this year. The government has been working on a plan since the end of last year to strengthen the competitiveness of homegrown new drugs and foster the pharmaceutical and bio industries. The industry has also consistently called for drug pricing incentives for homegrown new drugs that have proven non-inferiority to existing drugs, saying that more practical measures are needed to encourage innovative pharmaceutical companies. As such, the ministry held 5 public-private consultative body meetings and 6 working-group level meetings with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Biomedicine Industry Association, and the Korean Research-based Pharmaceutical Industry Association until June this year. Since then, the Ministry of Health and Welfare has taken time to organize the final draft, collecting opinions from related organizations in consideration of the financial soundness of insurance finances and feasibility. In addition, the MOHW had added other measures, such as adding drug price preservation plans for drugs with unstable supply and demand. Currently, the most promising plans include ▲ Flexible application of ICER thresholds by prioritizing innovation for pharmacoeconomic evaluation of innovative new drugs ▲ Preferential drug pricing for domestically developed innovative new drugs (apply highest price among alternative drugs) ▲ Preferential drug pricing for natural drugs at the same level as cell therapies ▲ Expansion of drugs for severe diseases that deteriorate the quality of life to be allowed exemption from pharmacoeconomic evaluative and applied RSA ▲ Application of RSA (dual drug pricing) for homegrown new drugs planned for exports. If the plan is finalized, the industry expects that the preferential pricing of homegrown new drugs and eased post-marketing management will improve the competitiveness of the drugs overseas and allow faster listing of innovative new drugs developed abroad that are urgently needed for patient treatment.
- Policy
- Novavax’s COVID-19 vaccine receives EUA in KOR
- by Lee, Hye-Kyung Dec 01, 2023 05:35am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced that it had granted emergency use authorization (EUA) for Novavax’s ‘Novavax COVID-19 Vaccine 2023-2024’ to respond to the Omicron subvariant (XBB.1.5). The Minister of Food and Drug Safety grants emergency use authorization when the head of relevant central administrative agencies requests a medical product that is not approved in Korea to appropriately respond to public health crises such as infectious disease pandemics, and allows the manufacturer or importer to manufacture or import medical products not approved in Korea. The EUA was granted after a review of the clinical and quality data submitted by the company, consultation with experts in various fields, then deliberation and resolution by the Medical Product Safety Management and Supply Committee. The Korea Disease Control and Prevention Agency had requested the use of Novavax’s vaccine in accordance with its national vaccination plan to prevent COVID-19 in the 2023-2024 winter season which is imported and supplied by SK Chemicals in Korea. Novavax's vaccine directly injects an antigenic protein made by genetic recombinant technology into the body to induce the production of antibodies that eliminate the virus The Pfizer and Moderna vaccines that are currently available are mRNA-based vaccines that express antigenic proteins to induce the body’s immune response. The Novavax vaccine has been granted EUA in the United States and is being used with formal approval in Europe. The Ministry of Food and Drug Safety said, "The introduction of Novavax’s vaccine in Korea holds significance as it expands the types of vaccines that can be used in the field. We will continue to strengthen the safe management of COVID-19 vaccines by carrying out thorough quality control measures and collection of adverse event reports to ensure that the public can receive the vaccination with peace of mind.”
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the gemcitabine and cisplatin used in the combination. Accordingly, the economic burden of the non-reimbursed Imfinzi + gemcitabine + cisplatin combination as first-line treatment for biliary tract cancer will be reduced to some extent with partial reimbursement approval. A HIRA official explained, "The CDDC decided to recognize part of the patient's out-of-pocket cost spent on gemcitabine and cisplatin that is used in combination with durvalumab. We plan to weigh the cost-effectiveness and report the results to the Ministry of Health and Welfare." If the MOHW recognizes the cost-effectiveness, it will amend the anticancer drug reimbursement standards so that only 5% of the drug cost for gemcitabine and cisplatin will have to be borne by the patient when used in combination with durvalumab. Gemcitabine’s insurance price ceiling is set at KRW 200,000 per vial, and cisplatin is also not expensive, costing less than KRW 20,000 per vial, so it seems likely that the reimbursement standards will be revised without complicated procedures. However, because Imfinzi, which is priced at KRW 3.34 million per vial, is non-reimbursed, the burden borne by the patients has not been completely resolved. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. The approval was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment naïve patients with unresectable locally advanced or metastatic biliary tract cancer. The Phase III trial results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a survival rate in the Imfinzi arm was 24.9% compared with 10.4% in the placebo arm at 2 years. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to the 5.7 months in the placebo arm. Since obtaining the indication, the non-reimbursed three-drug regimen has been widely used in the field for the primary treatment of biliary tract cancer. AstraZeneca applied for extended reimbursement in August in consideration of the burden borne by the patients, but failed at the first gate to reimbursement, at the CDDC level. However, the CDDC accepted the reimbursement for the other two drugs used in the combination in consideration of the patient burden and the high frequency of their use. An AstraZeneca official said, “We would like to express our gratitude to the government for showing the will to ease the burden of treatment costs for patients with biliary tract cancer, who are relatively elderly, have a poor prognosis, and have a progressive disease. Regarding the CDDC results, we have been conducting internal discussions to devise a measure to extend Imfinzi’s reimbursement to patients suffering from biliary tract cancer and the medical staff who work tirelessly day and night for their treatment.” “Considering the many HCPs and patients waiting to use Imfinzi, the first new standard treatment option and immunotherapy for biliary tract cancer that was introduced in 12 years, the company will continue to work with health authorities to expand its reimbursement in the future.” AstraZeneca is now left to decide whether to be content with the results or to reorganize the data and apply for reimbursement again.
