Based on the findings from this review, systemic corticosteroids are a common cause of AEs that may be costly to payers.

Data availability statement: Review article; no data/results provided in this publication.

Both authors are employed by Xcenda and develop AMCP Format dossiers.

Objectives: Leading medical professional societies (eg, ASCO, ESMO, NCCN) have recently released frameworks to facilitate discussions on the value of cancer therapies. This literature review summarizes recent trends on the concept of evaluating value in cancer care, using mCRC as an example. MethOds: Relevant publications were identified using predetermined search criteria in Medline (01/01/2005-12/31/2015) and abstracts presented at key conferences (01/01/2015-12/31/2015). Publications were reviewed if they addressed the following topics: providers/prescriber oncology value frameworks, factors influential for payer/reimbursement decision making in oncology, and components of "value assessment" in oncology. Results: From 13,914 unique results, 322 described mCRC-related pharmacotherapies; 90 met the inclusion criteria (46 in Europe and 39 in US; some covered > 1 country). Value evaluations published as journal articles increased more steadily across the review timeframe in Europe:

Objectives: To gain a better understanding of health-plan management of specialty pharmacy (SP), SP-products (2015 spending increased 21.5%) and diagnostic/ genetic testing (per-test costs declining,availability/use increasing). MethOds: Online survey of US medical+pharmacy directors from public/private plans with multiple member-types on: advisor+plan information; specialty-pharmacies/ pharmaceuticals, copays, and genetic/diagnostic test coverage and restrictions. Results: MDs represented 59% of respondents from plans representing commercial lives= 79.6%; Medicaid (low-income)= 61.1%; Medicare (elderly)= 68.5% with 28.6%= local; 41.1%= National; and 30.4%= regional. SPs were a top current/ future concern. 51.7% of plans restricted SP providers and 40.3% used their PBM as their SP, 46.1% of the SPs were privately-owned, 46.1% PBM-owned, and 7.7% hospital-IDN-owned. Top SP-conditions included HCV= 90.4%;Oncology= 88.5%;HIV= 73.1%. The majority (68.1%) restricted SP services to a small set under contract, 14.9% allow any SP; 14.9% only restricted products available through multiple specialtypharmacies, 2.1% carved them out. Plans covered clinician-administered products (CAPs, i.e., injections/infusions) under the medical-benefit (MB= 64.3%); under the pharmacy-benefit (PB= 5.4%); 30.4% were product-specific; 70.9% expect no change; and 29.1% expect to complete changes before 12-2018. Oral Biologics (OBs) were managed under the PB= 78.9%; the MB= 7.0%; 14.0% based on plan-design/product. Expectations for OB benefits: no change (78.6% of plans), currently changing (7.1%); before 12-2017 (12.5%) and before 12-2019 (1.8%). SP+OB copays vary by group/benefit design and are shifting from fixed to %-copays with Multiple-Sclerosis agents maintaining more fixed copays. Most (82.5%) of plans do not require AMCP-dossiers for testing. In 2016, genetic tests (GTs) were covered in all cases (63.5% of plans); not covered (15.4%) and threshold-based (21.1%) with minimal expected changes. GT coverage was highest for oncology (92.4%); OB/GYN (66.0%); cardiovascular (52.8%). Disease marker tests were covered in all cases (79.6%), not covered (5.6%), and 14.8% threshold-based. Coverage for therapy-response tests (HCV, RA, etc): all cases (68.5%), no-cases (20.4%); and 11.1% threshold-based. cOnclusiOns: Testing and specialty pharmacy/pharmaceutical expenditures are expected to grow and require appropriate coverage.

No abstract