Formulary Management & New-to-Market Medications

As part of MedOne’s commitment to clinical excellence and cost-effective care, the Formulary Management Sub-Committee of our larger Pharmacy & Therapeutics (P&T) Committee met recently to evaluate newly FDA-approved medications that came to market in Q2. These quarterly meetings determine if and where these new-to-market medications would be placed within our formulary. 

This review process ensures that our clients and members have access to the most appropriate therapies, aligned with both clinical value and financial sustainability.

Outlined below is a sampling of some of the drugs that were reviewed and the corresponding commentary and tier placement. These drugs, while approved by the FDA, have had little time in the market, so it can be difficult to assess their efficacy as well as their financial impact. Therefore, the sub-committee can deploy a “New-to-Market Block.” When placed on a specific drug during review, this delays placement, requiring more data to be present before moving forward. This notation was deployed on the following: 

Tryptyr (acoltremon)

Approved on May 28, 2025, Tryptyr is an ophthalmic solution used to treat the signs and symptoms of dry eye disease. While it introduces a new mechanism of action, the committee opted to place it on formulary as a Non-Preferred Brand with a New-to-Market Block, allowing time to assess comparative effectiveness and member response.

Andembry (garadacimab-gxii)

Approved on June 16, 2025, Andembry is a once-monthly injection treatment designed to prevent attacks of hereditary angioedema (HAE), or painful swelling of the arms, legs, face, throat and abdomen. As an orphan drug, it offers a targeted solution for a rare but serious condition. The committee placed Andembry on formulary as a Non-Preferred Brand Specialty with a New-to-Market Block, allowing time for further evaluation of real-world outcomes and pricing dynamics.

The orphan designation is awarded to drugs by the FDA alongside their approval. Orphan drugs treat rare diseases that affect a small percentage of the population, and there are often few to no treatment alternatives. While demand for these medications is typically low, the need (when it does arise) is urgent. As a result, these treatments tend to be very expensive and can place a significant financial burden on self-funded insurance plans. 

You may be aware that MedOne has an Orphan Drug Exclusion election built into our benefit specification form (BSF). This option to exclude certain orphan drugs allows for the prioritization of other treatments ahead of some of these therapies, protecting plan sponsor resources. Of course, if an orphan drug is deemed the best course of treatment for a member, this is evaluated in our clinical review process and addressed on a case-by-case basis. 

Several orphan drugs were up for discussion during this review session, including those outlined below. 

Avmapki Fakzynja Co-Pack (avutometinib + defactinib)

This combination therapy was approved on May 8, 2025, for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy. As an orphan drug, it addresses a niche but critical need in oncology. The committee placed it on formulary as a Non-Preferred Brand Specialty, recognizing its potential while maintaining cost oversight.

Ibtrozi (taletrectinib)

Ibtrozi received FDA approval on June 11, 2025, and is indicated for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This once-daily oral therapy is also designated as an orphan drug. Given its clinical relevance and specialized use case, it was added to formulary as a Non-Preferred Brand Specialty.

These were just four examples of how new-to-market medications can end up on formulary. Each medication is evaluated based on clinical efficacy, safety, cost-effectiveness, and alignment with MedOne’s mission to unlock the most appropriate prescription at the most affordable price. Our P&T Committee includes pharmacists, clinicians, and other intentional representatives who ensure that every formulary decision reflects our commitment to real results, real people, and real savings.