OBJECTIVES: Payers may grant coverage for bariatric surgery (BaS) for patients with BMI ≥ 40 or BMI 35-39.9 with ≥1 obesity-related comorbidities. Trial of weight loss (WL) medications before BaS may be beneficial to both payers and patients if some patients can avoid BaS. This analysis evaluated the cost impact of lorcaserin, a FDA- approved WL medication, in weight management prior to BaS from payer’s perspective. METHODS: Cost impact of lorcaserin for WL prior to BaS was assessed in a hypothetical US health plan of one million members over a 2-year horizon. Key assumptions include: 1) Average cost per BaS is $29,517; 2) Patients with BMI reduced to below 35 with pre-BaS WL can avoid BaS; 3) Only BaS and lorcaserin drug costs are included; 4) Only patients who achieve ≥5% weight loss at week 12 continue lorcaserin treatment (WK-12 responders). For modeling purpose, WL data for lorcaserin were drawn from a subset of patients in three clinical trials (BLOSSOM, BLOOM, BLOOM-DM) evaluating the efficacy and safety of lorcaserin for WL. RESULTS: 42.5% of patients with baseline BMI≥40 were WK-12 responders (average BMI 42.3) and 17.6% of them reduced BMI to below 35 at one year with lorcaserin treatment. In patients with baseline BMI 35-39.9 and ≥1 obesity-related comorbidities, 49.3% were WK-12 responders (average BMI 37.2), and 72.6% of them reduced BMI to below 35 at one year with lorcaserin treatment. The cost analysis estimated cumulative saving of $1,033,407 over 2 years if patients who reduced their BMI to below 35 with lorcaserin can avoid BaS. CONCLUSIONS: From payer’s perspective, using lorcaserin for WL prior to BaS may lead to significant cost saving over a 2-year horizon. Real world, long-term evidence is needed for further evaluation of the role of lorcaserin for weight management in patients considering BaS.
The Adoption is the conclusion of this process: (It is now only a formality)
REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. Within 15 days after receipt of the opinion referred to in
Article 5(2) (WHICH IS CHMP OPINION), the Commission shall prepare a draft of the
decision to be taken in respect of the application.
Where a draft decision envisages the granting of a marketing
authorisation, it shall include or make reference to the
documents mentioned in Article 9(4)(a), (b), (c) and (d).
Where the draft decision is not in accordance with the opinion
of the Agency, the Commission shall annex a detailed explanation
of the reasons for the differences.
The draft decision shall be forwarded to Member States and the
2. The Commission shall take a final decision in accordance
with, and within 15 days after the end of, the procedure
referred to in Article 87(3). (WHERE IT IS ADOPTED and published in the Register)
I believe that this is the CHMP review of the EPAR. This should be the second draft to remove the issues from the french and irish. CHMP gets a look see at the EPAR before published. If that is the case the EPAR will be published as soon as the CHMP have consensus. Unless there are new objections than this should be it.