PBMs, Policy, and the Human Cost of Delay in Metabolic Care

Due to the current benefit design, patients with obesity, diabetes and other related conditions are experiencing avoidable harm from delayed metabolic care as a result of prior authorization, narrow formularies, step therapy policies and high out of pocket costs. New oral and other formulations of metabolic medicines are poised to change the treatment paradigm for patients with diabetes, providing improved glycemic control and weight loss potential as well as major adverse cardiovascular events prevention for appropriate patients. However, these treatments are often denied or delayed due to current benefit design. Pharmacy Benefit Managers (PBMs) have significant influence on the cost of prescription medications as well as benefit design and structure. They determine what products will be considered “preferred” by a plan, what step therapy requirements will be implemented for certain products and classes, and how out of pocket costs will be calculated at the pharmacy counter. As a result, patients experience delays, gaps or unexpected changes in their prescription therapy which can cause patients to lose momentum in their overall health management, experience disease progression, and become disengaged from their physician and the healthcare system.

Why It Matters

Metabolic care is more than a number. Those numbers (A1C, BMI, LDL, BP) matter, because they reflect a patient’s risk for organ damage. But with type 2 diabetes, obesity, abnormal lipid levels, and hypertension so common, and all of these conditions so closely linked, patients and clinicians alike also need to consider the patient’s risk for heart disease and stroke, as well as long term risk for diabetes, obesity, abnormal lipid levels, and hypertension. Reducing these markers early and in a sustainable fashion is the best way to prevent long term complications like neuropathy, kidney failure, vision loss, and heart disease. Don’t wait. Starting treatment early is better than delayed treatment. There is nothing worse than hours in the waiting room pulling out from your pocket a wallet to pay for time and treatments that could avoid weeks of harm.

1) Clinical advances become reality but are not equally accessible to all patients.

Metabolic therapy has evolved far beyond what used to be simply recommended eating and exercise. By prescribing medication your physician can help you make healthier choices and achieve better metabolic numbers. Originally marketed as glucose lowering agents for people with diabetes by enhancing insulin secretion through the GLP-1 receptor, GLP-1 receptor agonists and newer dual incretin agents also have potent appetite suppressing properties leading to weight loss for overweight patients. Additionally, patients on these medications often see reductions in blood pressure and cholesterol levels as well as improvements in many other risk factors for cardiometabolic disease. Importantly, trials have shown these agents can even reduce risk of cardiovascular events in high risk patients. For many patients, these agents serve as a substitute for several medications improving compliance and quality of life.

There is a gap between science and reality. A treatment may receive the “thumbs up” from regulatory agencies regarding safety and efficacy. Then the question becomes will payers cover this treatment for patients who need it. Sometimes there are limitations as to which plans cover a given treatment within a particular product category and even within specific diagnostic categories. Moreover, certain medical indications may require a patient to have a higher or lower BMI in order to qualify for treatment. Patients may be denied coverage for a new medication because they have not failed behavior modification, or even because a clinician feels that a patient would derive greater benefit from an older medication currently categorized under a payer’s step therapy requirements. This is true even if the clinician determines that from a medical standpoint the newer treatment is best for the patient.

2) How PBM and Formulary Mechanics Cause Delays

Note: This is the second in a series, please review the

Pharmacy Benefit Managers (PBMs) significantly affect patients’ ability to access certain medicines. The way PBM’s place medicines on a formulary, the rules they set forth for utilization management, and how they apply cost sharing amounts to different medicines all impact patients’ access to medicines. For example, a medicine may be “covered” but it is difficult or time-consuming to obtain due to multiple prior authorizations and layered reauthorizations with strict timeframes to receive a refill for ongoing medication. Patients may also be restricted to a certain quantity of a medicine within a certain timeframe, required to use a specific pharmacy for certain specialty medicines, required to try and fail alternative medicines to treat a condition before accessing the prescribed medicine even if the alternatives may have problematic side effects or contraindications for the specific patient. Additionally, alternatives to prescribed medicines may have lower efficacy to treat a specific condition.

Although on a chart delays may look like days or even weeks at most, in real life these can be a killer. It is not uncommon for a doctor to have no idea that a life altering or saving treatment has been denied for months. A simple appeal can then change the decision in a matter of weeks only to reverse the decision a short time later. Meanwhile patients are left waiting months for effective treatment. Or they are treated with less than optimal treatment in the interim while depleting their resources. Alternatively, they may choose to pay out of pocket to avoid delays in the hope that a speedier diagnosis and treatment will save their life or improve their health. A major barrier to taking medication is that people feel blamed or judged during the treatment process.

3) The human cost of delay is not purely theoretical, but is a growing concern in the legal profession. Many law firms are facing the reality

Delays in the initiation or continuation of metabolic therapy can be particularly detrimental to patient outcomes. Patients with persistent hyperglycemia can feel tired, be waking up at night to urinate excessively, have slow wound healing, be more susceptible to infections, and experience severe and potentially life-threatening microvascular and macrovascular complications in the long term. Patients with untreated or undertreated obesity can feel inactive, have sore joints, have poor sleep, worsening reflux, and experience severe and potentially life-threatening cardiometabolic complications. Once a patient finds a regimen that works for them to promote function and control appetite, it can be discouraging to have to stop or decrease medication. Once a patient has gained weight on metabolic medications, it can be more difficult to get back to optimal control. Additionally, once a patient has experienced hypoglycemia, they can fear and be repelled by the possibility of recurrence.

Patients with significant weight and metabolic diseases experience considerable emotional impact due to weight stigma and denial of metabolic-focused treatment. As a result, patients may be hesitant to come in for needed follow-up appointments out of fear of another block to addressing their metabolic disease or shame and frustration related to not meeting unrealistic goals set by providers or insurance companies. Metabolic disease management requires continuity of care and regular monitoring of small increases in healthy behavior and medication management.

4) System costs rise when care is delayed

In the meantime while effective prevention is not implemented there will be increased downstream utilization of the health care system. As diabetes and cardiometabolic disease are not well controlled there will be more non-electric, emergency or urgent visits and hospitalizations. There will be increased long term costs of diabetes and cardiometabolic disease related kidney disease, cardiovascular events and disability which all come from and impact all parties, especially employers and payers. These costs over years must be paid.

Administrative and clerical tasks are also consuming clinicians’ time. Staff members are on the phone with payers processing prior authorizations, gathering information for denied claims, and tracking down physicians’ offices for missing information. Many providers report being burnt out from the administrative burden of their jobs. These tasks used to take seconds or minutes to complete, but now require minutes or hours. As a result, everyone – providers and patients – are waiting longer for appointments and have less face time with their clinicians – the very people trained to treat chronic illnesses through education, medication management, healthy lifestyle counseling, and co-ordination with other specialists such as dietitians and diabetes management educators.

5) Equity is shaped by benefit design

Administrative barriers can exacerbate health disparities faced by patients in under-resourced communities. Patients in lower wage jobs may not have enough flexibility in their work schedules to take time off to complete additional forms, go to additional appointments, or respond promptly to the insurer or pharmacy. Patients in high deductible plans and/or with coinsurance may find that approved medications are unaffordable. Patients living in rural settings may have to travel farther to find physicians who are comfortable managing complex and advanced medications. Patients from all backgrounds may struggle to access their medical records online, complete online prior authorization requests, or participate in telehealth visits due to lack of broadband access.

Patterns matter. While we see certain patterns of activity emerging in communities across the country, the reality is that these diseases are not distributed fairly or equally. While healthy food is available in many neighborhoods, food deserts are all too common and often coincide with areas lacking safe spaces for physical activity. Stress and other factors can further drive obesity and diabetes. However, as changes to coverage rules allow more patients to benefit from modern and effective therapy scheduled around their needs in a plan that meets their needs, health outcomes gaps can be compounded.

Who It Affects

Patients with conditions related to the cardiometabolic syndrome such as type 2 diabetes, obesity, fatty liver disease, high cholesterol, hypertension, and heart disease experience the greatest delay. Many are proactively seeking medical therapy to prevent serious adverse health consequences, to reduce their reliance on expensive prescription medication, to regain energy, and to protect their long term health. When patients are placed in a higher risk category and forced to wait for or denied of medically necessary therapy, they are deprived of the gains from which they could have continued to improve as they maintained an active healthy lifestyle. Unfortunately many medical therapy programs are developed with unrealistic program expectations that fail to account for the real life circumstances of obese patients, such as imposing too strict of a BMI cut-off for treatment, requiring patients to document prior participation in a medically supervised lifestyle modification program, or expecting patients to report on their weight on a monthly basis in a manner that is perceived as punitive.

1) Patients with complex risk profiles

Patients with multiple health conditions would be most impacted by potential delays in medication fill due to their other medical conditions. Patients with established cardiovascular disease, chronic kidney disease, sleep apnea, polycystic overy syndrome (PCOS) and severe insulin resistance would be impacted the most by delays in receiving needed prescription medications on time. In addition to potential adverse health effects resulting from exposure to the negative health effects of active cardiometabolic conditions, patients could be sent to the hospital due to worsened condition symptoms. Patients already on complex medication regimens could be negatively impacted by certain medication fill coverage restrictions that result in the need for patients or their providers to continually seek medication substitutions, dose changes or 15 day supplies of medications.

2) Primary care teams and specialists

Providers in settings such as Primary Care, Endocrinology, Cardiology, Nephrology, and Obesity Medicine spend an inordinate amount of time keeping up with rapidly changing formularies and coverage policies. Once an appropriate decision has been made regarding the medically necessary treatment of a patient, practitioners and staff then must expend significant time and effort justifying that decision to payers through the submission of prior authorization requests, denial notifications, and appeals. Administrative staff, including nurses and medical assistants, are often tasked with and spend most of their time completing these tasks. In smaller practices, this can become a financial unsustainable practice burden. We are seeking help to create a process that would support a dedicated prior authorization team.

Pharmaceutical prior authorization has taken a leap forward in complexity. As a result, specialists are working harder as specialists generalists in patient access. The increased complexity of patient access processes has driven referrals to endocrinology for a variety of reasons. Although the medical complexity of the case may not warrant a referral to a specialist such as an endocrinologist, referrals are being driven because the primary care physician finds it easier to obtain prior authorization for a particular medication (with its multiple dosage forms, administrative requirements, etc.) when a specialist’s signature is affixed to the request for prior authorization. This has added to the workload of the specialty clinics and their staff and has further delayed the patient’s care.

3) Pharmacists and care coordinators

Pharmacists, diabetes educators, and other care managers play a critical role linking patients with diabetes and their benefit plan. Describe to patients why certain diabetes medications are not included in their pharmacy benefit, identify cost effective alternatives on your plan’s formulary, and connect patients into manufacturer supported programs such as copay cards and patient assistance programs. While taking on this role has its rewards, there are corresponding challenges – emotional as well as operational.

4) Employers, payers, and health systems

While restricting coverage of some benefits can produce short term cost savings to employers and payers, they will pay increased costs related to complications, disability, and decreased productivity in the longer term. Some employers actually pay for the complications of obesity while denying their obese patients access to safe and effective anti-obesity medications. Those health systems which choose to restrict some benefits will pay for greater utilization and staff time to process additional administrative layers. Future health strategies that are cost-effective and in the best interest of the patient may be met with member resistance and turnover, eliminating any incentive to pursue prevention strategies that take several years to achieve cost savings.

5) Marginalized and low income communities

For patients with limited financial means, administrative complexity can be a barrier to access. Here, we mean time, advocacy, and internet access to complete forms and make phone calls to ensure that patients are able to receive their necessary medications. In addition, having a narrow network, few appointments, and high out of pocket costs for specialist care can make a medication that is covered by a patient’s insurance unaffordable. A process that requires annual reauthorization can be enough to stop treatment altogether for someone working two jobs, or caring for family. Or someone who has to travel hours to see a specialist.

What Changes

In order to deliver evidence based care in a timely manner with minimal disruption, we need to rethink how things are accessed. This means rethinking how supervision is done, moving away from a focus on dull paperwork that has little relevance to ensuring safe use or optimal functioning of equipment and consumables.

1) Reorient benefit design toward outcomes

Plans can reduce harm by lowering patient cost sharing for these medications and limiting step therapy for evidence based metabolic therapies in clearly defined circumstances. Patients who meet medical criteria for a medication should be covered for that medication regardless of whether it is a preferred agent on the formulary, and whether rebates can be negotiated for the medication. Formulary design can further support continuity of care by designating certain drug classes as protected (i.e., never subject to nonmedical step therapy) or by establishing continuity of therapy rules that prevent nonmedical switching once a patient is on and stabilizing on a particular medication. Finally, plans must recognize that obesity is a chronic medical disease and support long-term treatment with safe and effective obesity medications that are recommended for use by clinicians.

2) Simplify and standardize prior authorization

Prior authorization for medications should be electronic, transparent and timely with clear clinical criteria between the different plans. It would be helpful for there to be standard forms and standard criteria between plans to reduce redundant paperwork for our patients and offices. For reauthorizations, indications and safety considerations should be the reasons for which additional information is requested. Additional information requested should be pertinent to the clinical management of the patient and not a redundant recitation of information found in the office. For example, there is no reason that the patient’s name and dosage need to be reentered into the prior authorization system.

Fast tracking of the refill and adoption of continuity of care policies can help prevent unnecessary discontinuation and “rebound” symptoms or disengagement of patients from their treatment. In addition, once a patient is on a stable dose of and on adequate levels of medication, refills should not be delayed for processing of paperwork. Patients and their providers should also expect that any transition in coverage include a grace period for discontinuation of the previous method of payment and initiation of a new method of payment, as well as a grace period for discontinuation of the previous medication and initiation of the new medication.

3) Align incentives for value, not list price mechanics. While it’s typical to tie sales incentives to a product’s listed price, this doesn’t necessarily encourage customers to make the best choice. Instead, sales teams should be rewarded for helping customers select the offer that best fits their needs and provides the greatest value. By basing incentives on the overall value

We should consider how we are paying for cancer medications in this country. We should move away from models that reward expensive list prices and convoluted rebates, and move towards models that reward value and affordability. Value-based contracts should pay for value based on clinical outcomes for those populations for which we have data. Benefit design for individual patients should eliminate or cap out-of-pocket costs for therapy. Clinical value is of no value if it cannot be afforded.

4) Support clinics with administrative relief

Health systems and payers can improve the denial appeals process by equipping providers and staff with technology and support to keep them focused on patient care. Medium to large health systems and commercial payers may use standardized documentation templates and decision aids, and could consider creating dedicated teams to manage prior authorizations and process denials. Training providers, medical billers, and patient service reps on medical necessity and accurate coding and documentation can also help to streamline the process. Clinics and practices that care for safety net patients and/or have limited resources may require additional support to address appeals effectively.

5) Develop practical clinical pathways to continue to plan for ongoing management.

Record patient goals and functional outcome measures at initiation of therapy and include only relevant information in the authorization requests. Collect complete baseline data at initiation of therapy (e.g. A1C, weight, active comorbidities, prior therapy, treatment failures, physical limitations). Dose and treatment decisions and monitoring can be individualized for optimal glycemic control and relief of symptoms such as fatigue and physical limitations. Patients may have different goals of therapy (e.g. glucose control vs. mobility).

Continuity in formulary decisions should not cease at the point of default. Clinics should consider the expected formulary change throughout their treatment planning process. An expected change in formulary presents an early opportunity for clinics to schedule follow up appointments and consider alternative treatments prior to default. Patients and families should also be informed of steps that can be taken in the event of a denial by a pharmacy. Formulary changes should occur based on clinical considerations and not create a discontinuity in treatment.

6) Policies and practices to reduce patient delay.

Policy can prevent worst practices and promote transparency without being overly burdensome. This could include setting some timeframe to make a decision on certain topics of coverage, having clear formulary decision-making processes that outline the basis for a particular formulary listing and the number of times a particular medication will be re-submitted for reconsideration for continuation of coverage. Additionally, preventing nonmedical switching in situations where there could be potential clinical harm and providing patients with continuity of medication and dose for a certain timeframe. As it relates to transparency, this extends beyond price and outlines the implications of the coverage decision to patients, such as the out of pocket cost and a timeframe to access a medication that is under review.

7) Person centred at the point of delivery: ensuring care is planned and delivered around the individual’s needs.

clinics should provide a validational experience of illness, work to reduce stigma, and clarify the process of the treatment for their patients. clinicians should explain the process of treatment and its effects and assist patients with their appeals as necessary to maintain trust of the patient in both the clinician and program. clinics may wish to collaborate with advocacy organizations, providing a voice to and for both employers and insurers. Stories of positive change- whether measured by new physical abilities or other qualitative improvements in quality of life- provide substantial evidence to third party payers that timely and effective treatment of obesity is medically valuable.

References:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11482839/