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Managed Care in GYN Cancers
Considerations for Managed Care Professionals in the Care of Patients With Gynecologic Cancer

Released: June 05, 2024

Expiration: June 04, 2025

Laura R. Bobolts
Laura R. Bobolts, PharmD, BCOP
Kelly Romo
Kelly Romo, PharmD, BCOP
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Key Takeaways
  • Prescription cancer therapy management in patients with gynecologic cancers is becoming more complex; now more than ever, managed care professionals need to keep current with changes to clinical guidelines, new approvals, major publications, and other cost-related considerations through continued pharmacy education.
  • Several strategies exist that can help managed care professionals make informed decisions on the best cancer therapy based on current biomarker status, including preauthorization, split-fill programs, and even selective off-label use based on like-kind scenario and Medicare Benefit Policy Manual guidance.

The field of gynecologic cancer care is rapidly evolving, with a growing need for managed care professionals to remain up to date regarding the care of patients with these diseases. In this commentary, we share insights and recommendations for primary care providers and managed care pharmacists that were covered in a live webinar on gynecologic cancers following the 2024 Academy of Managed Care Pharmacy Annual Meeting.

Molecular Testing and Payer Coverage in Ovarian Cancer

Kelly Romo, PharmD, BCOP:
The major oncology societies—the American Society of Clinical Oncology (ASCO), Society of Gynecologic Oncology (SGO), European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN), and American College of Obstetricians and Gynecologists —all recommend that genetic counseling and testing be considered in women with a history of ovarian cancer. ASCO and SGO recommend genetic counseling and testing for all women with an ovarian cancer diagnosis, even in the absence of family history. ESMO, slightly differently, recommends that patients with high-grade ovarian cancer should be tested for a germline BRCA mutation, and considerations should be given for a somatic BRCA gene mutation, as well.

However, disparities exist regarding payer coverage for germline and somatic testing in patients with ovarian cancer. For instance, patients with Medicare or Medicaid are less likely to receive testing than those with private insurance. Similarly, those patients who are uninsured also would be expected to not receive testing compared with patients who are insured. Based on data from a meta-analysis of 35 studies, approximately 39% and 30% of patients with an ovarian cancer diagnosis were recommended for genetic counseling and received genetic testing, respectively.

From a managed care perspective, we want to ensure that payers have updated their policies regarding what should be covered. In particular, when guidelines are updated, there can be a lag from the time the new policy or approval comes out because of the process payers use to update their policy. We also want to ensure that we are staying on top of new approvals and guideline updates as they occur.

Helpful tips for keeping up to date with the molecular testing coverage include using the standard category 1, category 2A, and NCCN Biomarkers Compendium publications. In addition, we can leverage the Medicare national and local coverage decision standards, as well as any payer-specific policies, state legislative requirements, and FDA-approved companion diagnostic testing publications.

With the recent approval of trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate (ADC), for use in patients with solid tumors, including ovarian cancer, who have a HER2 immunohistochemistry score of 3+ and no other satisfactory alternative treatment options available, based on data from the phase II DESTINY-PanTumor02 trial, we still do not have a defined frequency of testing for ovarian, endometrial, or cervical cancer.

For other novel approved therapies—such as mirvetuximab soravtansine, an ADC targeting folate receptors in patients with platinum-resistant ovarian cancer—if a provider requested this treatment but did not include the folate receptor α biomarker, it would be a good opportunity for the managed care pharmacist to discuss testing for this biomarker. Mirvetuximab soravtansine is priced at almost $40,000 per month, so we want to ensure that it is used in the appropriate patients. By making sure that biomarker testing is done in a timely fashion, we can verify that the appropriate treatment selection is done and overall decrease inappropriate spend and unnecessary delays in preauthorizations.

Useful Managed Care Strategies

Kelly Romo, PharmD, BCOP:
There are many ways to manage the use of prescription cancer therapy from the payer perspective. Prior authorization is one that most clinical practitioners are familiar with. We must ensure that the appropriate clinical criteria are used for these, including whether it is a therapy guided by the use of a biomarker, as previously mentioned, or whether any step therapy is required.

Data from Magellan’s 2023 Medical Pharmacy Trend Report describe various strategies that were used in a survey of payers, including commercial payers, Medicare, and Medicaid. In that survey, we see that 96% of payers are using prior authorization and/or step therapy as their primary mode of management, followed by quantity limits at 90%. Reauthorizations were seen at 67% and split-fill programs at 57%. Clinical oncology pathways were utilized by 33% of payers. 

In general, for prior authorizations, I think the numbers might be a bit lower than reported, and I believe that may be due to some of the challenges that are seen regarding the appropriate timing of the request and who is making the request (eg, physician associate team member as opposed to the provider), among others.

Regarding quantity limits, as a managed care pharmacist, we use various types of edits to limit quantity of medication to ensure that there is not overutilization of any therapeutic oncology products. I am often surprised this is not a little bit higher, but it also can depend on the setup of the care plan.

Regarding prior authorization, employing a longer authorization period for the initial review may reduce the timing to reauthorize often. In my experience, I see prior authorization periods of approximately 6-12 months, but these also may vary based on the care plan itself, the therapy, and the expected duration of treatment.

Split-fill programs are those where the payer is able to modify the pharmacy benefit drug—for instance, an oral oncolytic—and in the dispensing process provide maybe a 14- or 15-day supply to the patient for approximately 2-3 months at the start of therapy. This is done to ensure that there is no “wastage” of the drug because of drug-dose modifications or drug discontinuation based on a patient not tolerating treatment or due to adverse events. Vial rounding techniques (eg, we can round within 10% of prescribed dose) also can be leveraged based on the Hematology/Oncology Pharmacy Association guidelines and NCCN support document listing many oncology drugs. This is another way we could safely reduce spending while maintaining efficacy and safety of the therapy for the patient.

As managed care professionals, we need to be thoughtful when employing the split-fill program. For instance, we have to think through various possibilities, including Risk Evaluation and Mitigation Strategies, discontinuation rates, product packaging, and whether the therapy itself is a good candidate to be included in the split-fill program. For example, I think about our PARP inhibitors, and you could probably include most of those, unless they have to be given in the original packaging.

Regarding site of service, also called site of care, we may redirect treatment from one facility to another, including a hospital outpatient department, professional office setting, ambulatory infusion site, or provider’s office.

These are some of the strategies at our disposal as managed care professionals, but we also must ensure that we are evaluating not only whether the overall treatment plan is efficacious and safe, but also whether it is cost-effective—for instance, what additional therapies the patient needs to receive in addition to the standard anticancer treatment (eg, other supportive care drugs that may increase the overall cost of care), inpatient admission rates, and emergency department visits. We must ensure that we are following the clinical criteria that have been developed for each medication and any appropriate off-label criteria, covered briefly below.

Helping Patients With Gynecologic Cancer Gain Access to Care

Laura R. Bobolts, PharmD, BCOP:
Several studies have demonstrated improvement in outcomes for the addition of immunotherapy to standard-of-care platinum-based chemotherapy in patients with advanced/recurrent endometrial cancer with mismatch repair deficient (dMMR) status/microsatellite instability–high disease. We have covered these and immunotherapy use in cervical cancer in more detail in another related commentary. However, that leaves out a group of patients with mismatch repair proficient (pMMR) status. The phase III DUO-E trial is exploring the quadruplet combination of durvalumab immunotherapy plus carboplatin/paclitaxel followed by maintenance durvalumab plus olaparib in this setting. In the pMMR population, the median progression-free survival (PFS) for the quadruplet was 15.1 months vs 10.2 months for the triplet and 9.6 months for chemotherapy only arm. A very timely question asked at the live webinar was: “Would the DUO-E trial results support the use of chemotherapy plus durvalumab and PARP inhibitor maintenance in pMMR patients, microsatellite stable, or only in another patient population?” I can comment that with add-on treatments, we must keep toxicities in mind and carefully choose the population that would benefit most. In patients with pMMR status, we see an HR of 0.55 vs 0.71 with the triplet—which is a significant (P <.0001) improvement in PFS—by adding olaparib in the maintenance setting. In the dMMR population, the HR was 0.41 for the quadruplet and 0.42 for the triplet. Obviously, the benefit is substantially larger for the quadruplet in the pMMR population, which perhaps may justify the added toxicity in that setting.

Managing Off-label Coverage Requests

Laura R. Bobolts, PharmD, BCOP:
When reviewing off-label coverage requests, think of your Medicare line of business. Why? Because Medicare has a wonderful Medicare Benefit Policy Manual, chapter 15, section 50.4.5, which provides guidance on how anticancer therapies and biologics are approved off-label for Medicare members. I bring up Medicare as an example because commercial and Medicaid typically follow a similar approach—albeit commercial could be a little more strictly managed compared with Medicare.

Examples of coverage determinations for off-label therapy include:

  • Not according to FDA label, but use is supported in one of the 5 compendiums, such as the NCCN Drugs and Biologics Compendium: For this, I am looking to see if the recommendation is category 1 or 2A within that compendium. The guidelines often mirror the compendium, although the compendium goes into far more detail. 
  • Uses not in NCCN: If not within a compendium, you may look for eligible scientific literature to support insurance coverage. Meaning, within this Medicare policy, they list 26 journals, including The New England Journal of Medicine, the Journal of Clinical Oncology, Lancet, Lancet Oncology, and Blood, among others. But in general, those are the ones where we commonly see our large clinical trials and oncology practices published. If the clinical trial where the drug being pursued is published in full text, and if the member—meaning the patient—is using that medication off-label in a manner similar to how that drug was studied in the clinical trial, the patient is of a similar scenario, and thus they would perhaps have been eligible for that study—meaning it is the right line of therapy, the right cancer, the right prior treatments if applicable, etc—then we can use that publication to support off-label insurance (ie, payer) coverage.

Kelly Romo, PharmD, BCOP:
We know that those patients on Medicaid also can have limited coverage, and I hope that we can get to a point where we have population-based genetic testing, and it is not based on insurance coverage. I also hope we can move the needle with some patients being able to receive remote genetic counseling and online genetic testing that may be able to assist populations who are presently underserved.

Your Thoughts?
What are your thoughts or questions on the available strategies and other options for prescription cancer therapy management in patients with gynecologic cancer? Answer the polling question and join the conversation by leaving a comment. Also, feel free to visit the overall program, including our on-demand webcast, downloadable slides, and another clinical commentary covering recent advances for ovarian, endometrial, and cervical cancer.

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Which of the following strategies are you currently using in your management of prescription cancer therapy for your patients with gynecologic cancer?

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