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FAQs: Equitable Care in OC
FAQs: Advances and Equitable Care in Ovarian Cancer

Released: April 11, 2023

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Key Takeaways
  • Clinical oncology pathways have a key role in managed care pharmacy, yet payers’ criteria for the selection of agents on pathway are not always clear.
  • The landscape for PARP inhibitors has changed recently, with indications for treatment in the recurrent setting being updated for niraparib, olaparib, and rucaparib.
  • Despite ocular adverse event concerns with newly approved mirvetuximab soravtansine, clinical pharmacists feel confident that prior experience with antibody‒drug conjugates has helped them prepare for the multidisciplinary management of ocular toxicities.

In this commentary developed from an Academy of Managed Care Pharmacy satellite symposium on advances and equitable care delivery for all patients with ovarian cancer, expert pharmacists Colleen Bohnenkamp, PharmD, BCOP, BCPS, and Laura R. Bobolts, PharmD, BCOP, answer audience questions on the optimal integration of PARP inhibitors as maintenance therapy for newly diagnosed ovarian cancer and the recently approved targeted therapy mirvetuximab soravtansine, an antibody‒drug conjugate (ADC) directed against folate receptor α, for platinum-resistant ovarian cancer. Click here to access the program page containing an on-demand webcast from the live meeting and the downloadable slides from the live presentation.

Why do some clinical oncology pathways appear to lack some of the commonly used PARP inhibitors? Are they lacking upkeep with updates, or is this intentional?

Laura R. Bobolts, PharmD, BCOP:
At this time, PARP inhibitors (niraparib, olaparib, and rucaparib) are approved as maintenance therapy in the frontline and recurrent settings for patients with advanced ovarian cancer and a complete or partial response to platinum-based chemotherapy, and use may be biomarker dependent (eg, BRCA/homologous recombination repair deficient alteration). Recently, the FDA indications for treatment with a PARP inhibitor were withdrawn if the patient had received either 3 or more (niraparib or olaparib) or 2 or more (rucaparib) chemotherapy regimens.

Clinical oncology pathways are a subset of evidence-based treatment protocols for specific cancers, stages, and lines of therapy selected from national guidelines based on efficacy, toxicity, affordability, and overall value. Clinical oncology pathways can serve as an important tool in steering toward high-quality, cost-effective cancer care. Regarding some payers’ clinical oncology pathways not including one PARP inhibitor or another, it could be that they have not updated their pathways with the latest data. Then again, the various PARP inhibitors (niraparib, olaparib, and rucaparib) have been approved for quite some time. In addition to efficacy endpoints, often a payer may look at the total cost of care in determining what to put on their pathway. As we saw when looking at that total cost of care in my presentation, the cost for PARP inhibitors can be quite high. Payers may not include PARP inhibitors in their pathways because of the overall cost, combined with the progression-free survival only benefit; they may still be determining where the value lies with these therapies.

How close are we to a quality seal on pathways that provides rapid updates for the best care of our patients?

Laura R. Bobolts, PharmD, BCOP:
That is a difficult question to answer. I would say that because payers implementing oncology pathways must be very up to date and continually evaluate the available therapies, the quality seal is always a moving target. They might not meet as regularly—perhaps quarterly—limiting their ability to make rapid updates. However, oncology changes daily, which is why I would say that, from the payer’s perspective, pathways are more often than not leveraged to incentivize high-quality care vs approve or deny therapy.

I do not think a universal pathway will happen any time soon because different payers may have a different determination of a value for a given therapy. Conversely, we do not want our patients to be 100% on the pathway. We know every patient is an individual. When payers are looking at pathway compliance, we usually look for an approximately 75% to 80% compliance rate, knowing that you can expect that 20% to 25% deviation for individualization.

What are your thoughts when a clinical oncology pathway from the payer’s side does not align with the pathway from the provider’s side?

Laura R. Bobolts, PharmD, BCOP:
In that scenario, it is recommended that providers implementing a pathway have open discussions with their key payers and vice versa. For example, a large cancer center may say to a payer, “What do you have on pathway?” Those payers, we hope, are willing to share that data and have an open discussion about what is on the pathway and what should be covered based on the patient’s particular situation. I often see payer and provider pathways have good alignment. Where I do see differences in payer- and provider-side pathways is regarding use of a preferred biosimilar. To avoid any roadblocks in pathway adoption, there needs to be an open discussion, and we must revisit the pathways and see how they are performing over time.

Why would a payer’s pathway program not include a National Comprehensive Cancer Network category 1 designated treatment?

Laura R. Bobolts, PharmD, BCOP:
This is uncommon but can happen when there are multiple National Comprehensive Cancer Network category 1 therapies in a similar space. If there are multiple therapies, the payer first may look for data supporting an overall survival benefit and have that particular treatment on their pathway. Should there be multiple therapies in a similar space with an overall survival benefit, that is where I may see a payer leaning on a given option that better fits their specific criteria for value.

Are there any screening modalities in patients who are at a higher risk for developing ovarian cancer?

Colleen Bohnenkamp, PharmD, BCOP, BCPS:
Unfortunately, the short answer is no. There are no effective screening tools for ovarian cancer, as in other gynecologic cancers, such as cervical cancer. The CA-125 test is a tumor marker that we follow in certain patients after they have a confirmed diagnosis of ovarian cancer. Unfortunately, the CA-125 marker is not a specific test only for ovarian cancer, as we can see increases in CA-125 in patients with endometriosis or pelvic inflammatory disease—that is, other conditions may influence CA-125 status.

However, in patients newly diagnosed with ovarian cancer, if we can detect more germline BRCA mutations than we would have otherwise with routine genetic testing, this can help us guide patient discussions about familial testing by involving a geneticist to help patients inform their families of what risks they may have.

For additional information on risk factors and molecular testing in patients with ovarian cancer, download a patient-centered resource here.

Are survival rates lower because of delays in diagnosis for racial and ethnic minority patients?

Colleen Bohnenkamp, PharmD, BCOP, BCPS: 
Data show that survival rates are lower not only because of delays in diagnosis, but also because of lower receipt of guideline-concordant care. That may include lack of guideline-directed therapy in managing the patient’s disease, particularly not following through with adequate surgical procedures. We also have seen higher rates of delays in receipt of chemotherapy and more frequent dose reductions and/or discontinuations among Black patients.

What kind of anemia is associated with PARP inhibitor therapy? Iron deficiency? B12?

Colleen Bohnenkamp, PharmD, BCOP, BCPS: 
When we are evaluating anemia in patients receiving PARP inhibitors, we do a workup to determine the source. What we find usually is not related to iron or B12 deficiency. We often see increases in mean corpuscular volume, which would lead us to think of a B12 deficiency. However, the anemia we see is unique to PARP inhibitor use and has a rapid onset―within the first few months. Fortunately, with proper monitoring and management of PARP inhibitor therapy, most adverse events (AEs) subside over time.

Mirvetuximab soravtansine AEs are very similar to belantamab mandolin, which recently was withdrawn from the market. What are your thoughts on that?

Colleen Bohnenkamp, PharmD, BCOP, BCPS: 
Mirvetuximab soravtansine is an ADC that was approved recently for adult patients with folate receptor α‒positive ovarian, fallopian tube, or primary peritoneal cancer that is refractory or resistant to platinum-based chemotherapy after 1-3 previous chemotherapies. Belantamab mafodotin is another ADC that was approved for hematologic cancers. When belantamab mafodotin was approved, it had an associated Risk Evaluation and Mitigation Strategy, as well. Much of what we learned from the safety profile of belantamab mafodotin, including ocular toxicity, has demonstrated the benefit of using prophylactic eye care and having patients undergo regular eye exams by an ophthalmologist or optometrist before beginning therapy and after every other dose with mirvetuximab soravtansine. I do think that we have learned much at our institution from our experience with belantamab mafodotin, and we now are better able to manage the ocular AEs that may be seen in patients receiving mirvetuximab soravtansine for ovarian cancer.

If a patient fails to comply with the recommended eye drops used to mitigate ocular AEs with mirvetuximab soravtansine, should one stop therapy after a patient already has received a few cycles?

Colleen Bohnenkamp, PharmD, BCOP, BCPS: 
This is a scenario where we rely on our eye care providers to help guide us in continuing therapy. For us specifically, patients must be receiving corticosteroids and lubricating eye drops, and the ophthalmologist or optometrist refills the corticosteroid prescriptions for them. If the patient is not compliant with their ocular visits, or if they are having any ocular toxicity, we would then consider stopping therapy. Aside from this, it can be challenging to know if a patient is compliant with their eye drops and if they are not having any ocular AEs, because some of it is self-reporting. Again, we rely on that ocular exam to guide us on continuation of therapy.

Your Thoughts?
What challenges have you encountered in using clinical oncology pathways and managing AEs with novel therapies, including PARP inhibitors or ADCs? Join the conversation by answering the polling question below and visiting the ProCE website for more content, including free downloadable and editable slides and on-demand webcasts from the live event.


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