PRICENTRIC BRIEF:
- The Centers for Medicare & Medicaid Services (CMS) has released a statement proposing coverage of Biogen’s Aduhelm (aducanumab) but only extending the decision to patients who are enrolled in qualifying clinical trials – the decision means a narrow coverage for the controversial Alzheimer’s therapy, which garnered criticism from the wider industry when it was approved by the Food and Drug Administration (FDA) in June last year.
- The European Commission (EC) has granted conditional marketing authorization for Amgen’s first-in-class KRASG12C inhibitor, Lumakras (sotorasib) – due to the conditional marketing authorization, continued approval in the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- The U.S. Government is purchasing an additional 600,000 doses of GlaxoSmithKline (GSK) and Vir’s investigational early COVID-19 treatment, sotrovimab – branded as “Xevudy” – for delivery through Q1 of 2022, as well as a further 500,000 doses of AstraZeneca’s Evusheld for the pre-exposure prevention of COVID-19, anticipated in the first quarter of 2022.
THE DETAILS
COVID-19
The European Medicines Agency (EMA) has begun its evaluation of Pfizer’s Paxlovid (PF-07321332 and ritonavir) for the treatment of mild to moderate COVID-19 in patients, including adolescents, who are at high risk of progression to severe COVID-19. Under the assessment, the EMA will assess the benefits and risks of the therapy under a reduced timeline, hoping to issue an opinion within weeks, dependent on the level of data submission and further information required.
The U.S. Government is purchasing an additional 600,000 doses of GlaxoSmithKline (GSK) and Vir’s investigational early COVID-19 treatment, sotrovimab – branded as “Xevudy” – for delivery through Q1 of 2022. Under the agreement, the U.S. also has the option to purchase additional doses in Q2 of 2022. The Emergency Use Authorization (EUA) for Xevudy permits its use as treatment for mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.
The U.S. has also agreed to purchase a further 500,000 doses of Evusheld for the pre-exposure prevention of COVID-19, anticipated in the first quarter of 2022, announced AstraZeneca. This deal follows a previous agreement for the purchase of 700,000 doses.
The EMA has expressed “doubts” about the need for repeated or even fourth doses of COVID-19 vaccines. Speaking at a media briefing, the Agency’s Head of Vaccines Strategy, Marco Cavaleri, suggested that boosters do “not represent a sustainable long-term strategy,” despite being part of contingency plans. He clarified, “It’s not something that we can think should be repeated constantly.”
On January 12, 2022, a group of regulatory agency leaders from around the world met to discuss a global strategy against the omicron strain of COVID-19. The workshop, which was co-chaired by the EMA, U.S. Food and Drug Administration (FDA), and the International Coalition of Medicines Regulatory Authorities (ICMRA), reviewed available COVID-19 vaccines and their respective efficacy against the omicron wave.
POLICY
With the introduction of AB 1400, the California Guaranteed Health Care for All Act – dubbed “CalCare” – and Assembly Constitutional Amendment (ACA) 11, California is pursuing the implementation of single-payer healthcare for all Californians.
The Institute for Quality and Efficiency in Health Care (IQWiG) has suggested that medicines for rare diseases should undergo a regular benefit assessment procedure when entering the market.
Russian President Vladimir Putin declared intent to increase the age limit for recipients to over 18, during a telephone conversation broadcast by Russia’s 24 TV channel.
Sonia Tarragona, Chief of Cabinet of the Ministry of Health, and Roberto Feletti, Secretary of Internal Trade, met with representatives of Argentina’s pharmaceutical industry last week, including CAEME, CILFA and COOPERALA, to reach a consensus on measures to improve access to medicines through implementing reference prices and promoting prescriptions by generic names. As explained by Tarragona, reference prices will be updated monthly according to the percentage increase in the simple average of the wage index and the consumer price index prepared by the National Institute of Statistics and Censuses (INDEC). To start, a list of active principles of 85 drugs was agreed to, involving approximately 230 reference prices and 1,200 pharmaceutical presentations.
Through a partnership with Merck Serono Middle East and Al Manzil healthcare services, the UAE Ministry of Health and Prevention (MOHAP) has set up a program called “Rawan” to provide health insurance to those with partial coverage, along with free medicines.
HTA
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) in combination with carboplatin and paclitaxel for the treatment of untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, following data collection through the Cancer Drugs Fund.
Following an evaluation of new data and collection of real-world evidence (RWE), the NICE has turned down BioMarin’s Vimizin (elosulfase alfa) for the treatment of mucopolysaccharidosis type 4A (MPS 4A).
France’s High Health Authority (HAS) has approved an extension of indication for the reimbursement of Sanofi’s Sarclisa (isatuximab), recommending it for the treatment of adult patients with multiple myeloma who have received at least one previous treatment, when used in combination with Kyprolis (carfilzomib) and dexamethasone.
Norway’s decision-making council for new methods (Nye Metoder) has announced that nine methods will be considered in its January meeting, including the blockbuster Keytruda and a few orphan drugs, such as Evrysdi and Epidyolex.
PRICING & REIMBURSEMENT
The Institute for Clinical and Economic Review (ICER) announced it has published a Final Evidence Report assessing the comparative clinical effectiveness and value of Eli Lilly’s tirzepatide for the treatment of type 2 diabetes. ICER determined in its report that the health-benefit price benchmark (HBPB) range for tirzepatide is between $5,500 and $5,700 per year, considering assumptions about long-term cardiovascular benefits that have not yet been directly demonstrated in clinical trials.
According to the Federal Joint Committee (G-BA), Germany had its most successful year yet in terms of therapy assessments in 2021, completing 146 procedures and handing out five “significant additional benefit” ratings.
Through Resolution 27/2022, the Ministry of Health of Argentina is establishing reference prices for 85 active pharmaceutical ingredients (APIs) that cover all medicines with the same API involving approximately 230 reference prices and 1,200 pharmaceutical presentations, according to the ministry. The health ministry detailed that reference prices are calculated by considering retail prices for medicines pulled from the National Drug Vademecum of the National Administration of Drugs, Foods, and Medical Devices (ANMAT), with reimbursement dependent on whether the retail price exceeds the reference price.
The Centers for Medicare & Medicaid Services (CMS) has released a statement proposing coverage of Biogen’s Aduhelm (aducanumab) but only extending the decision to patients who are enrolled in qualifying clinical trials. The decision means a narrow coverage for the controversial Alzheimer’s therapy, which garnered criticism from the wider industry when it was approved by the Food and Drug Administration (FDA) in June last year.
DRUG APPROVAL
The U.S. Food and Drug Administration (FDA) has granted aTyr Pharma orphan drug designation (ODD) for its lead therapeutic candidate, ATYR1923, for the treatment of sarcoidosis. The potential first-in-class immunomodulator downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states and is currently undergoing a phase 1b/2a study in patients with pulmonary sarcoidosis.
The European Commission (EC) has granted conditional marketing authorization for Amgen’s first-in-class KRASG12C inhibitor, Lumakras (sotorasib). Due to the conditional marketing authorization, continued approval in the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Blue Note Therapeutics, a prescription digital therapeutics company focused on oncology, announced that the FDA has granted Breakthrough Device Designation for BNT200.
Basilea announced that its licensing partner, Pfizer, has bagged National Medical Products Administration (NMPA) of China approval for the oral formulation of Cresemba (isavuconazole) for the treatment of adult patients with invasive aspergillosis.
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