NAVLIN BRIEF:
- The Kingdom of Saudi Arabia (KSA) has initiated the development of its own clinical guidelines. Publishing the first issue of the Saudi Journal of Clinical Pharmacy (SJCP), Ahmed Al-jedai, Deputyship of Therapeutic Affairs at the Ministry of Health, outlined the aims, missions and values of the guidelines. Going forward, the guidelines are intended to “contribute [to] and enhance the dynamic field of clinical pharmacy in the context of KSA’s ever-changing healthcare environment with promises of a better and healthier future”. Saudi Arabia currently uses either international reference pricing (IRP) or therapeutic reference pricing to establish the price of medicines; however, according to EVERSANA Data Analyst Aatiqah Thanvi, after they are published, the SFDA could potentially use the guidelines to influence price decisions.
- The Plain Prescription Prices Act introduced by U.S. Congress members Bryan Steil (R-WI), Nikema Williams (D-GA), Don Bacon (R-NE) and Angie Craig (D-MN) would ensure prescription drug commercials aired on TV disclose the list price of the medicine being advertised. Steil commented, “I am proud to co-lead the Plain Prescription Prices Act, which requires drug manufacturers to disclose drug prices in consumer ads”, adding, “This simple move can increase transparency and provide patients with the options they deserve”. Former U.S. President Donald Trump’s plan to require drugmakers to reveal the price of their drugs in TV ads was struck down in June 2019 by U.S. District Judge Amit Mehta, who ruled that HHS does not have the power to mandate price disclosure from drugmakers in TV ads; only Congress does.
- The European Commissioner for Health and Food Safety, Stella Kyriakides, has said that the EU Commission has no plans to “overhaul” its legislation on advanced therapy medicinal products (ATMPs) but will “look at ATMP-specific characteristics” in its upcoming review of pharmaceutical rules. Speaking at the Cell & Gene Meeting on The Med in Barcelona, Spain, Kyriakides said: “[Our] strategy recognizes that for innovation to take root, Europe’s companies need a fertile environment offering regulatory flexibility, legal certainty, a conducive intellectual property regime and the necessary infrastructure“. Kyriakides believes that the Commission’s pharmaceutical strategy and drug legislation reform will give the EU “a chance to improve” its system and “adapt it to the latest scientific developments“.
THE DETAILS
COVID-19
Polish Health Minister Adam Niedzielski has announced that Poland plans to stop accepting COVID-19 vaccines under the EU-led joint procurement initiative. The move, which could entangle the country in legal battles with various producers such as Pfizer – its key supplier – is due to surplus stock that it is already trying to shift to other countries.
Ocugen has now secured commercialization rights to Covaxin in all of North America after amending its co-development, supply and commercialization agreement with Bharat Biotech for the COVID-19 vaccine to include Mexico. Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We are delighted to announce our partnership with Ocugen for Mexico, along with the United States and Canada”, adding, “We are fully supportive of team Ocugen in our endeavour to expedite technology transfer activities towards commercial scale manufacturing of Covaxin in North America”.
The World Health Organization (WHO) has recommended Pfizer’s oral antiviral COVID-19 treatment, Paxlovid (nirmatrelvir and ritonavir), calling it the “best therapeutic choice” for high-risk patients to date. However, despite the high praise from the WHO, it underscored that that availability, lack of price transparency in bilateral deals made by the producer, and the need for rapid and accurate testing before administering it “are turning this life-saving medicine into a major challenge for low- and middle-income countries”.
The Institute for Quality and Efficiency in Health Care (IQWiG) has determined that Gilead’s Veklury (remdesivir) offers “non-quantifiable added benefit” for unvaccinated adults with COVID-19 disease who do not require additional oxygen supply and have an increased risk of developing a severe course of COVID-19. In a release, Gilead determined the annual therapy costs of the drug amounted to EUR 2189.60, while a single vial of Veklury costs EUR 547.40 (direct purchase: manufacturer selling price of EUR 460 plus 19% VAT). IQWiG stated that “only outpatient treatment with Veklury was examined in the study. In addition, patients who had received at least one vaccination against SARS-CoV-2 were excluded from the study. As a result, only patients without vaccination protection were considered in the GS9012 study”.
The head of the World Trade Organization (WTO), Ngozi Okonjo-Iweala, told the media that four involved parties are currently seeking to agree on final terms for the proposed intellectual property waiver for COVID-19 vaccines. “People are saying the text is now being rejected. It is not true“, Director-General Okonjo-Iweala clarified to Reuters on Thursday. “They are still trying to iron out the last things. It’s just the last few tweaks”. The call for a patent waiver first appeared in communication from India and South Africa on the waiver of various chapters of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement on October 2, 2020.
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Novavax and Takeda’s Nuvaxovid, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.
The High Health Authority (HAS) of France has announced that its economic and public health evaluation committee (CEESP) is set to evaluate Pfizer’s Paxlovid (nirmatrelvir + ritonavir) for the treatment of COVID-19.
POLICY
The Kingdom of Saudi Arabia (KSA) has initiated the development of its own clinical guidelines. Publishing the first issue of the Saudi Journal of Clinical Pharmacy (SJCP), Ahmed Al-jedai, Deputyship of Therapeutic Affairs at the Ministry of Health, outlined the aims, missions and values of the guidelines. Going forward, the guidelines are intended to “contribute [to] and enhance the dynamic field of clinical pharmacy in the context of KSA’s ever-changing healthcare environment with promises of a better and healthier future”. Saudi Arabia currently uses either international reference pricing (IRP) or therapeutic reference pricing to establish the price of medicines; however, according to EVERSANA Data Analyst Aatiqah Thanvi, after they are published, the SFDA could potentially use the guidelines to influence price decisions.
The Plain Prescription Prices Act introduced by Congress members Bryan Steil (R-WI), Nikema Williams (D-GA), Don Bacon (R-NE) and Angie Craig (D-MN) would ensure prescription drug commercials aired on TV disclose the list price of the medicine being advertised. Steil commented, “I am proud to co-lead the Plain Prescription Prices Act, which requires drug manufacturers to disclose drug prices in consumer ads”, adding, “This simple move can increase transparency and provide patients with the options they deserve”. Former U.S. President Donald Trump’s plan to require drugmakers to reveal the price of their drugs in TV ads was struck down in June 2019 by U.S. District Judge Amit Mehta, who ruled that HHS does not have the power to mandate price disclosure from drugmakers in TV ads; only Congress does.
Representatives from the Ministry of Health, Public Health, and Healthcare Networks of Chile are working with the Senate Health Commission to realize legislative reforms regarding healthcare in Chile in 2022. For the health ministry, the main areas of focus are COVID-19, lowering waiting times, and mental health, as well as implementing universal healthcare and boosting access to medicines.
The Irish Minister for Health, Stephen Donnelly, has received Cabinet approval to develop the General Scheme of a Health Information Bill. The aim of the bill, according to the department of health, is to ensure that Ireland has a “fit for purpose” national health information system that enhances patient care and treatment and supports better planning and delivery of health services.
U.S. Senators Shelley Moore Capito (R-WV), Sherrod Brown (D-OH), Jon Tester (D-MT) and James Lankford (R-OK) have penned a letter to the Office of Management and Budget (OMB) urging a quick review of the Centers for Medicare and Medicaid Services’ (CMS) proposed rule to lower out-of-pocket prescription drug costs for seniors. The policy from CMS, which would take effect on January 1, 2023, would require Medicare Part D plans and pharmacy benefit managers (PBMs) to apply all price concessions they receive from network pharmacies at the point of sale, reducing beneficiary cost-sharing.
The European Commissioner for Health and Food Safety, Stella Kyriakides, has said that the EU Commission has no plans to “overhaul” its legislation on advanced therapy medicinal products (ATMPs) but will “look at ATMP-specific characteristics” in its upcoming review of pharmaceutical rules. Speaking at the Cell & Gene Meeting on The Med in Barcelona, Spain, Kyriakides said: “[Our] strategy recognizes that for innovation to take root, Europe’s companies need a fertile environment offering regulatory flexibility, legal certainty, a conducive intellectual property regime and the necessary infrastructure”. Kyriakides believes that the Commission’s pharmaceutical strategy and drug legislation reform will give the EU “a chance to improve” its system and “adapt it to the latest scientific developments”.
HTA
According to a publication in the Official Gazette (JO), France has ended its early access scheme (ATU) for Roche’s Gavreto (pralsetinib) as a treatment for RET fusion-positive non-small-cell lung cancer (NSCLC). The therapy was given a cohort ATU in March 2021 as monotherapy for adults with locally advanced or metastatic RET fusion-positive NSCLC who had received at least one platinum salt-based treatment.
The Institute for Quality and Efficiency in Health Care (IQWiG) has assessed Keytruda (pembrolizumab) in combination with Lenvima (lenvatinib) for the treatment of renal cell carcinoma (RCC) and determined that the therapy combination offers “no added benefit” due to a lack of data.
The IQWiG has also assessed Janssen’s Rybrevant (amivantamab) and determined that the therapy offers “no added benefit” for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with activating EGFR-Exon 20 insertion mutations. According to IQWiG, the decision was based on the fact that Janssen did not provide appropriate data comparing the therapy to the designated comparator therapies: docetaxel alone or in combination with Boehringer Ingelheim’s Ofev (nintedanib), or pemetrexed as monotherapy.
The High Health Authority of France (HAS) has decided to decline the early access scheme (ATU) submission to Amgen and AstraZeneca’s (AZ) Tezspire (tezepelumab) or the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.
In a reassessment, the Innovation Committee of the Federal Joint Committee (G-BA) has found Takeda’s Ninlaro (ixazomib) in combination with lenalidomide plus dexamethasone offers “non-quantifiable added benefit” for patients with multiple myeloma (MM) who have received at least one prior therapy.
PRICING & REIMBURSEMENT
France’s Transparency Commission (CT) has agreed to reimburse Hansa Biopharma’s Idefirix (imlifidase), as it offers “moderate additional therapeutic value (ASMR III)” when compared with standard therapy, according to the organization. To come to the conclusion, the CT considered that the drug had substantial therapeutic value on its own merit, granting it ASMR III based on pre-transplant efficacy data and post-transplant survival proven in an open-label phase II trial.
The IQWiG has determined that Pfizer’s Cibinqo (abrocitinib) offers “considerable added benefit” for some adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. The determination is based on the randomized control study (RCT) JADE DARE, submitted by Pfizer, which compared the treatment with Cibinqo to Dupixent over the course of 26 weeks. Some 362 patients were treated with Cibinqo and 365 with Dupixent. IQWiG noted that the launch price of a new drug is determined by the manufacturer and is maintained for one year while health technology assessment (HTA) procedures are completed and the manufacturer and umbrella payer group, GKV-Spitzenverband (GKV-SV), negotiate pricing. The release also shows that a 100-mg dose of Cibinqo is shown to cost EUR 16,447.70 a year, while a 200 mg dose has a cost of EUR 20,458.45.
The Italian Medicines Agency (AIFA) has announced that it recognizes Pierre Fabre Medicament’s Braftovi (encorafenib) as potentially innovative for some colorectal cancer. AIFA noted that in Italy, Braftovi has an ex-factory price of EUR 2,587.49 and a public price of EUR 4,270.39 for a box of 42 capsules dosed at 75 mg and the same prices for a 28-capsule box dosed at 50 mg; however, an obligatory price discount is applied when the drug is sold for use in the public health system.
A Turkish patient dubbed “ZA” with advanced lung cancer has successfully won against the Social Security System (SGK) in court after the patient had to fund treatment with Roche’s Tecentriq (atezolizumab). The patient bought Tecentriq from abroad after being told by a physician that chemotherapy and radiotherapy would not be applicable and then requested that SGK cover the expenses because Tecentriq is not included on the reimbursement list. The Ankara Administrative Court ruled in favour of ZA, finding SGK’s refusal to reimburse the patient a violation of the patient’s right to health, an interim decision the patient’s lawyer Eliz Atlı called “unprecedented”.
DRUG APPROVAL
Health Canada has approved Merck’s Keytruda (pembrolizumab) as treatment for adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery.
The U.S. Food and Drug Administration (FDA) has accepted GlaxoSmithKline’s New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).
The FDA has granted Priority Review to Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the U.S. with unresectable or metastatic non-small-cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The FDA has accepted AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) with a Prescription Drug User Fee Act (PDUFA) date set for the third quarter of 2022.
The FDA has granted Fast Track Designation to Keymed Biosciences CMG901 as monotherapy for the treatment of patients with unresectable or metastatic gastric and gastroesophageal junction cancer who have relapsed and/or are refractory to approved therapies.
The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s posoleucel for the prevention of clinically significant infections and disease from six devastating viruses that commonly impact high-risk adult and paediatric patients following allogeneic hematopoietic cell transplant (allo-HCT) – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV).
PTC Therapeutics has released a statement announcing that the European Medicines Agency’s (EMA) committee for advanced therapies (CAT) is planning to make a recommendation on its gene therapy treatment for AADC deficiency as soon as May.
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