Rubraca - NC Standard

Restricted Product(s)

• Rubraca® (rucaparib)

FDA Approved Use

• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
• For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)–associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. The patient has a diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; AND 
   1. The patient has recurrent disease; AND 
      1. The patient will be using for maintenance while in complete or partial response to platinum- based chemotherapy; OR 
5. The patient has a diagnosis of metastatic castration-resistant prostate cancer; AND 
   1. The patient has a deleterious BRCA mutation [medical record documentation required]; AND 
   2. The patient has previously been treated with androgen receptor-directed therapy and a taxane based chemotherapy; AND 
   3. The patient will concurrently receive a gonadotropin-releasing hormone (GnRH) analog; OR 
   4. The patient has undergone a bilateral orchiectomy; AND 
6. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. (Medical records and references / evidence must be provided); AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

November 2022: Criteria change: Removed the indication for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Formatting changes.
May 2020: Criteria update: Added new indication for metastatic castration-resistant prostate cancer.
Apr 2018: Coverage expanded to recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers in accord with expanded FDA indication.
Jun 2017: Criteria format updated; New to market strength, 250 mg, added to policy; Deleterious BRCA documentation language changed.
Apr 2017: Original utilization management criteria issued.