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When it comes to generating high-quality evidence applicable to clinical care, the alcohol field has lagged behind other medical-scientific fields, according to Dr Richard Saitz, a recent presenter at Yale University Medical School. Dr Saitz is Professor of Medicine and Epidemiology and Director, of the Clinical Addiction Research and Education (CARE) Unit Section of General  Internal Medicine, at Boston University Schools of Medicine and Public Health. 

Research-Based Approaches to Treating Alcohol Use in Primary Care

A 4.5-cm annular lesion on this patient’s hand is similar to lesions found elsewhere on his body. The patient reports no symptoms. The skin is smooth and without scale. Visible is a ring of firm multiple papules. Treatment with a steroid ointment was unsuccessful.

The patient has similar lesions elsewhere on his body. Treatment with a topical steroid was unsuccessful. Can you ID?

Clinical Topics

A Ring of Firm Multiple Papules 

A 5-year-old boy with a history of atopic dermatitis since 6 weeks of age, presents with a rash around his mouth that has been present for approximately 1 year. The patient’s mother reports that desonide topical cream was applied to the affected area for about 5 days, which initially resulted in improvement, however the rash returned after this medication was discontinued. The rash also recently improved after the patient took amoxicillin for an infection. She also notes that the patient has been licking his lips more frequently.

On examination there is an erythematous papulopustular eruption restricted to the perioral region, with sparing of the vermillion border. Mild hyperpigmentation is noted on the patient’s neck. There is no active involvement of other areas of the body.

The eruption has been present for 1 year and is restricted to the perioral region. What is included in your differential? 

Rash Around the Mouth of a 5-year-old Child

United Kingdom’s health regulator approved

 a new treatment for Alzheimer’s disease, the country’s cost-effectiveness regulator recommended nixing national coverage for it.

Since new Alzheimer’s disease treatments are available only to patients in the early stages of the disease, the potential impact on geriatricians, family doctors and other primary care physicians, who are responsible for approximately 

, cannot be overstated. In fact, when the 

proposed noncoverage policy from the National Institute for Health and Care Excellence (NICE)

 for the drug, called Leqembi, is finalized this fall, an estimated 70,000 patients living with early Alzheimer’s in the UK will be denied access to it.

Good thing that would never happen in the United States to treatments approved by the Food and Drug Administration (FDA) — but it is, and it’s been going on here for more than a year.

Like in the U.K., the Medicare program and other public and private payers in the United States have set up rationing barriers to Leqembi and a second, 

newer FDA-approved drug in the same class

Medicare has barred coverage unless beneficiaries agree to participate in what the Centers for Medicare & Medicaid Services (CMS) calls coverage with evidence development (CED) for these early Alzheimer’s therapies

. Under a CED, Medicare indiscriminately mandates that beneficiaries enroll in clinical studies for coverage of selected treatments, or else coverage will be denied. CMS also imposes strict eligibility criteria on the health professionals and hospitals that can qualify to collect data and run the studies. The net effect is only a small fraction of Medicare beneficiaries get access to FDA-approved treatments subject to CED, with communities of color far too often underrepresented in the required studies.

, Medicare has applied CED over the last 20 years to procedures for severe hearing loss (cochlear implants), less-invasive heart valve replacement, and stem cell transplant for certain cancers and sickle cell disease. The report documents that the CED policy has largely been a failure in yielding meaningful evidence development or expanding timely access. Yet, ignoring the evidence, CMS in April 2022 applied the policy to Alzheimer’s disease medications — the first time Medicare applied CED to an on-label use of an FDA-approved drug. 

 released last month indicate it will not be the last.

Other public and private payers have followed CMS’ lead. 

 is denying beneficiary access to Leqembi, Kisunla and all future drugs in the same class. TRICARE is the uniformed services health care program for more than 9.5 million active duty and retired service members and their families. Coverage policies from the private insurer, Cigna, call 

 “experimental, investigational, or unproven” despite FDA approval and deny coverage for both medications. Several other private payers are using complex guidelines to deter utilization.

Most families contending with Alzheimer’s know that, just like most cancer drugs do not cure cancer, Leqembi and Kisunla do not cure early Alzheimer’s disease. However, like many cancer drugs, clinical trials of these Alzheimer’s therapies have shown effectiveness in delaying disease progression. A recently published study that modeled long-term scenarios found that starting the treatments during the early symptomatic stages of Alzheimer’s disease 

could delay severe dementia by four to seven months using conservative estimates, and potentially up to two to four years

. This is particularly important for people living with early disease, as cognition, personality and ability to care for oneself slowly decline with each passing day.

risk of side effects related to Leqembi is low

, especially compared with almost any cancer drug. Yet, because Alzheimer’s is a deadly disease primarily affecting older adults, it is 

more likely to be underdiagnosed and undertreated

 recklessly refer to people living with early Alzheimer’s as “relatively healthy” following the decision to ration access to new treatments. We wonder — would they say the same about someone living with a small, malignant tumor? Probably not.

The annual list price for Leqembi, $26,500, has been slammed in the press. Piling on, CMS officials have wildly overblown cost projections as justification for raising Part B Medicare premiums and increasing Medicare Advantage (MA) provider payments due to the purported cost of Alzheimer’s treatments.

Medicare’s restrictive coverage policies are denying patients with early Alzheimer's disease access to novel treatments. And private payers are following suit.

Dear Payers: Drugs for Early Alzheimer's Disease are ‘Worth It’

Richard Saitz, MD, MPH

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