By: Henry Lee, Consultant, DKI Health Published: April 2023 Insights from DKI Health’s Patient and Caregiver Advisory Roundtable

It sounds obvious: patients should have power in choosing treatments that are best for them. But in reality, they face opaque prescription drug prices and a payment system seemingly designed to confuse rather than cover them.

DKI Health met with our Patient and Caregiver Advisory Council to learn from their experiences and their ideas for how patients’ voices can be heard in drug pricing, reimbursement, and market access.

PAYER RESTRICTIONS IMPACT PATIENTS’ WELL-BEING

Payers in the United States (including health insurance companies and government agencies) use numerous tools to restrict patient access to medicines. Such “utilization management” measures can burden healthcare providers, impact patient care, and result in negative patient outcomes. These include:

Prior Authorization requires providers to justify their prescription or patient treatment before it is covered. This often involves significant paperwork, lab tests, or other proof of need—and creates more work for already overwhelmed provider offices.1

For example, among patients who were prescribed a class of medicines to lower cholesterol (LDL) levels called PCSK9 inhibitors, 80% were initially denied coverage by their health insurers.2 Such denials, delays, and frustrating back-and-forth communication patients must often manage can lead them to abandon or nd alternatives to their best course of care.

-Sue Koob, CEO, Preventive Cardiovascular Nurses Association

Step Therapy requires patients to try a medicine that the payer prefers—often an older treatment, or one for which the payer has negotiated a lower cost—and fail on that treatment before they can receive the medication they and their prescriber want.3 This may also lead to disease progression, new symptoms, side effects, and other poor results for patients—and higher treatment costs.4

Sickle cell disease patients face significant unmet needs, and until recently had few options for treatment. While recent approvals of Adakveo and Oxbryta have offered patients hope, lagging access has left hopes unfulfilled: a recent survey of Medicare providers found more than half place access restrictions (step therapy and/or prior authorization) on Adakveo, and more than 80% restrict Oxbryta.5

-Alisha Lewis, Founder and CEO, Genèsic Nonprofit Organization

Copay Accumulators block copay assistance from counting towards a patient’s out-of-pocket maximum or deductible, undermin-ing the intent and value of programs that millions of Americans rely upon to afford their medications.6

-Jen Grand-Lejano, Government Relations Director, American Cancer Society Cancer Action Network

SUPPORT THE WHOLE PATIENT AND FIND A TRUE ALLY

Two opportunities our advisors shared for patient engagement on access are:

Empower patients through education on treatment pricing, the stakeholders involved, and patients’ influence in the system.

Support access across the treatment journey, as patients must navigate utilization management on more than drugs.

-Phil Gattone, President, Elevate for Impact

CONCLUSION

It is said that knowledge is power—and if patients are to have power in choosing treatments that are best for them, they need and deserve the knowledge to make those choices. DKI Health believes that stakeholders who recognize the untapped power of patient voice in market access, and who provide the right tools and education to empower patients, will see gains well beyond what they invest.

U.S. LEGISLATION ON DRUG ACCESS UNDER CONSIDERATION

The Safe Step Act:7 Introduced in 2021 and endorsed by more than 200 patient advocacy groups8, would require group health plans to provide certain step therapy exemptions and make clear the process for gaining an exemption. The Act’s design is similar to laws passed in 36 states (as of February 2023).

-Congressman Raul Ruiz, M.D.

The Help Ensure Lower Patient Copays Act:9 Introduced in 2021 and supported more than 75 national patient and provider advocacy groups,10 would address copay accumulators by requiring group and individual health plans to apply payments made on behalf of plan en-rollees toward plan’s cost-sharing requirements. The Act’s design is similar to laws passed in 16 states (as of February 2023

-Kollet Koulianos, Senior Director of Payer Relations, National Hemophilia Foundation

REFERENCES

1. Examining Prior Authorization in Health Insurance. Kaiser Family Foundation, 20 May 2022, www.kff.org/policy-watch/examining-prior-authorization-in-health-insurance/. Accessed 30 March 2023.

2. Nasir, Khurram. PCSK9 Inhibitors Prior Authorization. Circulation, 2019, https://doi.org/10.1161/CIRCOUTCOMES.119.005910. Accessed 20 March 2023.

3. Step Therapy. Healthinsurance.Org, www.healthinsurance.org/glossary/step-therapy/. Accessed 30 March 2023.

4. Step Therapy (Fail First). National Organization for Rare Disorders, rarediseases.org/policy-issues/step-therapy/. Accessed 30 March 2023.

5. Andelson, Emma et al. Medicaid Access & Landscape Review For Prescription Drugs Treating Sickle Cell Disease. Sick Cells and Avalere Health. 2022. Accessed 13 April 2023.

6. Copay assistance should count as part of patients’ cost sharing for medications. STAT News, 30 June 2021. https://www.statnews.com/2021/06/30/copay-assistance-health-insurers-pbms-count-toward-cost-sharing-requirement/. Accessed 13 April 2023.

7. Safe Step Act. Congress.Gov, 10 April 2019, www.congress.gov/bill/116th-congress/house-bill/2279. Accessed 1 March 2023.

8. S. 464/H.R. 2163, SAFE STEP ACT OF 2021. Crohn’s & Colitis Foundation, 2 December 2022, www.crohnscolitisfoundation.org/sites/default/files/2020-04/Safe%20Step%20Act_2020%5B1%5D.pdf. Accessed 1 March 2023.

9. HELP Copays Act. Congress.Gov, 1 November 2021, www.congress.gov/bill/117th-congress/house-bill/5801/text. Accessed 1 March 2023.

10. National Patient Organizations Join Forces to Ensure Copay Assistance Counts for Patients. PR Newswire, 10 February 2023, www.prnewswire.com/news-releases/national-patient-organizations-join-forces-to-ensure-copay-assistance-counts-for-patients-301744296.html. Accessed 1 March 2023.