Formulary Watch

Sotatercept — now with the brand name Winrevair — will be available through specialty pharmacies by the end of April. The price of Winrevair is $14,000 per vial.

Medicare Part B beneficiaries may save between $1 and $3,575 per average dose for the 41 drugs whose prices have risen higher than inflation.

J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with pulmonary arterial hypertension.

FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.

The full approval was based on the confirmatory phase 3 MIRASOL trial, which showed that Elahere resulted in a 33% reduction in risk of death and a 35% reduction in the risk of cancer progression.

Medicare and Medicaid will cover Wegovy for its recently approved indication to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and obesity.

Duvyzat is an oral nonsteroidal drug that works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy. It will be available in the third quarter of 2024.

This follows AstraZeneca’s and Boehringer Ingelheim’s announcements to also cap their asthma chronic obstructive pulmonary disease drugs at $35.

Tryvio, an oral drug for those with uncontrolled hypertension, will be available in the second half of 2024. The list price has not yet to be determined.

Zymfentra, with a price of $6,181.08 for two shots over four weeks, is approved as maintenance therapy for adults with ulcerative colitis and Crohn’s disease.

The accelerated approval of Iclusig for patients with acute lymphoblastic leukemia and with the Philadelphia chromosome was based on a surrogate endpoint. Iclusig has a list price of $20,831 for 30 tablets.

In a recent survey, payers said the Inflation Reduction Act will help lower patients’ out-of-pocket costs, but they were concerned about Medicare’s drug price negotiation and the IRA’s impact on formulary management.

Lenmeldy (atidarsagene autotemcel) is the first gene therapy to treat children with juvenile metachromatic leukodystrophy (MLD).

The FDA has assigned a goal date of Aug.13, 2024, for Lymphir to treat patients with relapsed or refractory cutaneous T-cell lymphoma.

AstraZeneca also said it had reduced the list price of Symbicort beginning Jan. 1, 2024.

Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

Breyanzi is the first CAR-T therapy to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Madrigal Pharmaceuticals is pricing Rezdiffra (resmetirom) at wholesale acquisition price of $47,400 per year.

Livmarli is now approved to treat the itching associated two different rare liver diseases: progressive familial intrahepatic cholestasis and Alagille syndrome.

One lot of treprostinil injection is being recalled. Tresprostinil is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension.

The new collaboration gives Prime access to Capital Rx’s secure claims system JUDI, which Capital Rx leaders say was developed with enhanced security protocols.

In 2021, pediatric mental health conditions were associated with $31 billion in child spending and $59 billion in household spending, which made up 46.6% of all pediatric medical spending that year.

The additional indication is for chhildren as young as 8 years of age with heterozygous familial hypercholesterolemia.

GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.

The submission is for the same indications, including Xolair’s recently approved indication IgE-mediated food allergy.

Michigan’s state Medicaid agency has signed an outcomes-based agreement for Lyfgenia patients with sickle cell disease. The agreement provides payers with risk sharing tied to vaso-occlusive events-related hospitalizations

It can now be used to reduce the risk of cardiovascular death, heart attack and stroke in overweight patients with heart disease.

Regulators want to discuss safety issues, as well as the phase 3 trial’s design where patients were treated based on an assessment of amyloid plaque and the inclusion of patients based on tau protein levels.