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- The German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-Finanzstabilisierungsgesetz), proposing a number of measures including an increased mandatory discount on patented drugs from 2023 and a new restriction in the current “orphan privilege” rule. Perhaps the most impactful change of the proposed bunch, previously announced plans to backdate Pharmaceuticals Market Reorganisation Act (AMNOG) rebates to six months after launch (instead of the current 12-month free pricing period) will be implemented, saving up to EUR 150 M per year.
- This week, the Senate Finance Committee held a hearing on “Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare,” in which senators debated, essentially, whether to allow Medicare to negotiate drug prices. There was little agreement across party lines on allowing Medicare to negotiate drug prices, but Iowa Senator Chuck Grassley (R) pushed for the passing of his bipartisan 2019 Wyden-Grassley Prescription Drug Pricing Reduction Act (PDPRA) that “… caps out-of-pocket expenses at $3,100, eliminates the donut hole [and] caps rising drug prices in Medicare at the inflation price index – ending uncapped taxpayer-funded subsidies to Big Pharma,” explained the senator.
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has added possible side effects to the packaging of both Janssen and Moderna’s COVID-19 vaccines. At its most recent PRAC meeting, the committee recommended that small vessel vasculitis with cutaneous manifestations should be added to the product information of Janssen’s COVID-19 vaccine as a possible side effect of unknown frequency. Additionally, the group suggested Moderna should include a warning for flare-ups of capillary leak syndrome (CLS) to the product information for its vaccine Spikevax.
France will begin offering a fourth COVID-19 vaccination shot to people aged 80 and older who had their previous booster dose more than three months ago, French Prime Minister Jean Castex told daily Le Parisien in an interview published on Saturday. Speaking to Le Parisien, the Prime Minister said, “The over-80s will be able to make an appointment again — they represent 4.1 million French people, and among them, 3.1 million have already had three doses. But not all will be eligible since you have to wait three months after the last injection. This new campaign will also be extended to immunocompromised people who were not eligible until now.”
AbbVie announced it is joining forces with Scripps Research, an independent biomedical research institute, to develop novel, direct-acting antiviral treatments to tackle COVID-19. Research will kick off at Calibr, the drug discovery and development division of Scripps Research, with initial funding from the Bill & Melinda Gates Foundation.
Pfizer and its partner BioNTech have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose of Comirnaty for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
The World Trade Organization (WTO) has welcomed the consensus from four of its WTO members on key elements of a long-sought intellectual property waiver for COVID-19 vaccine. It was reported earlier this week that four WTO members (United States, European Union, India and South Africa) came to a tentative agreement to authorize the use of “patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic.” Director-General Ngozi Okonjo-Iweala of the WTO said, “This is a major step forward, and this compromise is the result of many long and difficult hours of negotiations.” However, all 164 WTO member countries must accept any agreement in order to be adopted. Okonjo-Iweala added: “We have more work to do to ensure that we have the support of the entire WTO membership.”
Colombia’s National Institute for Food and Drug Surveillance (INVIMA) announced it is in talks with Merck over the purchase of the company’s COVID-19 treatment, molnupiravir, and is reviewing a number of concerns.
This week, the Senate Finance Committee held a hearing on “Prescription Drug Price Inflation: An Urgent Need to Lower Drug Prices in Medicare,” in which senators debated, essentially, whether to allow Medicare to negotiate drug prices. There was little agreement across party lines on allowing Medicare to negotiate drug prices, but Iowa Senator Chuck Grassley (R) pushed for the passing of his bipartisan 2019 Wyden-Grassley Prescription Drug Pricing Reduction Act (PDPRA) that “… caps out-of-pocket expenses at $3,100, eliminates the donut hole [and] caps rising drug prices in Medicare at the inflation price index – ending uncapped taxpayer-funded subsidies to Big Pharma,” explained the senator.
According to sources in Italy, the upcoming rare disease framework is behind schedule. The framework was initially meant to be approved in February, but the decree has still not been passed despite being approved by the Hygiene and Health Commission of the Senate last year. The chamber also voted unanimously in favour of passing the decree last November, without changing the text that was first presented to them in May 2021.
The German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-Finanzstabilisierungsgesetz), proposing a number of measures including an increased mandatory discount on patented drugs from 2023 and a new restriction in the current “orphan privilege” rule. Perhaps the most impactful change of the proposed bunch, previously announced plans to backdate Pharmaceuticals Market Reorganisation Act (AMNOG) rebates to six months after launch (instead of the current 12-month free pricing period) will be implemented, saving up to EUR 150 M per year.
U.S. Energy and Commerce Committee Chairman Frank Pallone Jr. (D-NJ) has introduced the Accelerated Approval Integrity Act that would ensure accelerated-approval products provide proven clinical benefit to patients. The accelerated approval program was established to allow for earlier approval of drugs intended for serious conditions, based on a surrogate endpoint that predicts clinical benefit. Essentially, the FDA can approve drugs without confirmation of clinical benefit at the time of approval, as long as follow-up studies conducted by companies demonstrate that the drug does in fact offer clinical benefit.
Boehringer Ingelheim’s Jardiance (empagliflozin) has been recommended by the National Institute of Health and Care Excellence (NICE) as a treatment option for adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). In a caveat to the recommendation, Jardiance can only be used as an add-on to optimize standard care with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin two receptor blocker (ARB) with a beta-blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA); or sacubitril valsartan with a beta-blocker and, if tolerated, an MRA. The technology appraisal guidance shows the list price of 10 mg or 25 mg Jardiance is £36.59 per 28-tablet pack (excluding VAT), while the annual treatment cost is £476.98; however, NICE said that costs may vary in different settings because of negotiated procurement discounts.
NICE has also recommended Janssen’s Darzalex (daratumumab) for the treatment of some patients with relapsed and refractory multiple myeloma. The recommendation covers individuals who have had a proteasome inhibitor and an immunomodulator and whose disease progressed on the last treatment but only if they receive Darzalex after three treatments and the company provides the therapy according to the commercial arrangement. In its Final Appraisal Document (FAD), NICE noted the list prices of Darzalex as £4,320 per 1,800 mg/15 ml solution for injection vial, £360 per 100 mg/5 ml concentrate for solution for infusion vial and £1,440 per 400 mg/20 ml concentrate for solution for infusion vial.
The Institute for Quality and Efficiency in Health Care (IQWiG) has determined that Roche’s Gavreto (pralsetinib) has “no added benefit” to treat adults with advanced non-small cell lung cancer (NSCLC). Gavreto is indicated as monotherapy for treating adult patients with rearranged during transfection (RET) fusion-positive advanced NSCLC who have not been previously treated with an RET inhibitor.
PRICING & REIMBURSEMENT
The Economic Committee on Healthcare Products (CEPS) in France has announced plans to create a generic pricing group (TFR) for pemetrexed from 1 April. According to the country’s Official Gazette (JO), the group currently contains Alimta, marketed by Eli Lilly, with a number of generics from other companies, such as Fresenius, Krka, Medac and Pfizer, among others.
The High Health Authority (HAS) of France has published a favourable opinion for reimbursing Eisai’s Kisplyx (lenvatinib) plus Keytruda (pembrolizumab) for the treatment of clear cell only kidney cancer.
At its March 7 meeting, the Agency for Health Technology Assessment and Tariff System’s (AOTMiT) Transparency Council (TC) assessed coverage of Lamzede (velmanase alfa) and Forxiga (dapagliflozinum) for the treatment of mild to moderate alpha-mannosidosis and chronic kidney disease with eGFR, respectively.
Techniker Krankenkasse (TK), one of Germany’s largest pharmaceutical payers, has issued a statement calling for “immediate measures” to be placed on patented medicines, which could potentially save up to EUR 8 billion for the healthcare system in Germany. According to the payer, the recently published “Innovation Report 2021” shows that in Germany, pricing for new medicines “needs to be redesigned,” as “not enough medicines come onto the market that patients really benefit from.”
MSD’s PD-L1 inhibitor Keytruda (pembrolizumab) was approved for reimbursement in South Korea for the treatment of non-small cell lung cancer (NSCLC) and Hodgkin’s lymphoma. Keytruda will now be reimbursed as monotherapy or in combination with chemotherapy for patients with non-squamous or squamous cell lung cancer in the first-line treatment of three types of NSCLC, regardless of PD-L1 expression.
Servier has announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its Tibsovo (ivosidenib) in two indications as a first-line treatment, in combination with azacitidine, in patients with previously untreated IDH1-mutated acute myeloid leukaemia (AML) and who are not eligible for intensive chemotherapy, as well as in previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma.
The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to AstraZeneca regarding its supplemental Biologics License Application (sBLA) for Fasenra (benralizumab), announced the company. The sBLA is for the use of Fasenra in patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) and included phase 3 data that met both primary endpoints and showed a good safety profile.
The FDA has approved AstraZeneca and MSD’s Lynparza (olaparib) for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
The FDA has also approved AbbVie’s Rinvoq (upadacitinib) for its first indication in gastroenterology, announced the company.
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