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Vijoice (alpelisib) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-91198
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Vijoice® (alpelisib) Tablets, Oral Granules |
Treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
PIK3CA-Related Overgrowth Spectrum (PROS) |
PIK3CA-related overgrowth spectrum (PROS) is a group of genetic disorders that result in overgrowth of various body parts due to mutations in the PIK3CA gene. A broad number of disorders fall into the spectrum, with some genetic and symptom overlap between the different disorders. The PIK3CA gene is involved in making a protein that helps regulate cell growth, division, and survival. Mutations to the PIK3CA gene happen spontaneously during development in the womb. There are a number of subtypes of PROS and include:(2)
PROS is caused by somatic mutations in the PIK3CA gene. There are a variety of activating mutations of the PIK3CA gene associated with each syndrome with some genetic overlap between the different syndromes. These somatic mutations occur during prenatal development and are said to be somatic mosaic mutations, where the mutations are present in only certain cells of the body affecting only certain areas of the body, leading to overgrowth in only certain body regions or asymmetrically.(2) The PIK3CA gene leads to the creation of the protein known as p110a, and mutations in this gene result in an abnormally active PI3K enzyme. With increased activity, affected cells grow and divide more rapidly, leading to abnormal bone, soft tissue and blood vessel growth. PIK3CA mutations may also cause overgrowth by influencing the effects of growth factors and hormones on nearby and distant cells. Mutations in the PIK3CA gene have been found in certain cancers of the lower GI tract, the ovaries, breasts, brain and liver. Currently, most patients with PROS do not appear to be at a significantly higher risk for cancer. The only cancer reported in PROS to date has been Wilms tumor, the most common pediatric kidney cancer in very young children.(2) Due to the phenotypic overlap and variability, the diagnosis of PROS can be complicated. Referral to a physician with expertise in the diagnosis and treatment of PROS is recommended. Biopsy of the overgrown tissue and genetic testing for PIK3CA variants are required to confirm the diagnosis of PROS.(2,3,4) The National Institute of Health (NIH) Clinical Diagnostic Criteria for PROS include the following:(3)
*- If no mutation identified, consider as presumptive PROS Treatment is dependent on the syndrome and symptoms present. Treatment options can include the following:(2)
|
Efficacy |
The efficacy of Vijoice was assessed in EPIK-P1 (NCT04285723), a single-arm clinical study in patients who were treated as part of an expanded access program for compassionate use. Eligible patients 2 years of age and older with PIK3CA-related overgrowth spectrum (PROS) who received Vijoice had clinical manifestations of PROS that were assessed by the treating physician as severe or life-threatening and necessitating systemic treatment and had documented evidence of mutation in the PIK3CA gene.(1) The efficacy of Vijoice was evaluated in a total of 37 patients with at least one target lesion identified on imaging performed within 24 weeks prior to receipt of the first dose of Vijoice. Ninety-two percent of patients had congenital overgrowth and 8% had early childhood-onset. The major efficacy outcome measure for the study was the proportion of patients with radiological response at week 24 as determined by blinded independent central review (BICR), defined as a greater than or equal to 20% reduction from baseline in the sum of measurable target lesion volume (1 to 3 lesions) confirmed by at least one subsequent imaging assessment, in the absence of a greater than or equal to 20% increase from baseline in any target lesion, progression of non-target lesions, or appearance of a new lesion. An additional efficacy outcome measure was duration of response, defined as the time from the first documented response to the date of the first documented disease progression or death due to any cause. Of the patients treated with Vijoice 10 were considered responders, and of those patients 7 sustained response for greater than or equal to 6 months and 6 sustained response for greater than or equal to 12 months.(1) |
Safety |
Vijoice is contraindicated in patients with severe hypersensitivity to alpelisib or any of its ingredients.(1) |
REFERENCES
Number |
Reference |
1 |
Vijoice prescribing information. Novartis Pharmaceuticals Corp. April 2024. |
2 |
National Organization for Rare Disorders (NORD) Rare Disease Database. PIK3CA-Related Overgrowth Spectrum (PROS). Accessed at: https://rarediseases.org/rare-diseases/pik3ca-related-overgrowth-spectrum/ |
3 |
Keppler-Noreuil KM, Rios JJ, Parker VER, et al. PIK3CA-Related Overgrowth Spectrum (PROS): Diagnostic and Testing Eligibility Criteria, Differential Diagnosis, and Evaluation. Am J Med Genet A. 2015 Feb;0(2):287–295. |
4 |
Kuentz P, St-Onge J, Duffourd Y, et al. Molecular Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) in 162 Patients and Recommendations for Genetic Testing. Genet Med. 2017 Sep;19(9):989-997. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Vijoice |
alpelisib (pros) oral granules packet |
50 MG |
M ; N ; O ; Y |
N |
|
|
Vijoice |
alpelisib (pros) pak ; alpelisib (pros) tab therapy pack |
125 MG ; 200 & 50 MG ; 50 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Vijoice |
alpelisib (pros) oral granules packet |
50 MG |
28 |
Packets |
28 |
DAYS |
|
|
|
Vijoice |
Alpelisib (PROS) Pak |
200 & 50 MG |
56 |
Tablets |
28 |
DAYS |
|
|
|
Vijoice |
Alpelisib (PROS) Tab Therapy Pack |
50 MG |
28 |
Tablets |
28 |
DAYS |
|
|
|
Vijoice |
Alpelisib (PROS) Tab Therapy Pack |
125 MG |
28 |
Tablets |
28 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Vijoice |
alpelisib (pros) oral granules packet |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vijoice |
alpelisib (pros) pak ; alpelisib (pros) tab therapy pack |
125 MG ; 200 & 50 MG ; 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Vijoice |
alpelisib (pros) oral granules packet |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vijoice |
Alpelisib (PROS) Pak |
200 & 50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vijoice |
Alpelisib (PROS) Tab Therapy Pack |
125 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Vijoice |
Alpelisib (PROS) Tab Therapy Pack |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 6 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 6 months for initial; up to 12 months for renewal |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Vijoice_PAQL _ProgSum_ 10-01-2024