Meeting News

Drug costs, prior authorizations create barriers to timely cancer care

Neeraj Agarwal

High drug costs and regulations requiring prior authorization of treatment plans are barriers to cancer treatment that can affect clinical outcomes for patients, according to results of two studies scheduled for presentation at Quality Care Symposium.

The studies independently examined high out-of-pocket costs of oral tyrosine kinase inhibitors for patients with non-small cell lung cancer and prior authorizations for imaging that may delay and inhibit cancer care.

“The high costs of cancer care have many facets that often result in barriers to accessing timely and consistent care,” Neeraj Agarwal, MD, ASCO expert who was not involved with either study, said in a press release. “High out-of-pocket drug costs, shown here with oral anticancer drugs, are associated with a lower number of prescriptions, shorter duration of therapy, and inferior cancer-associated outcomes. Another aspect is the administrative burden seen in one study that finds a vast majority of prior authorizations are redundant, and a close collaboration between hospitals and insurers can help eliminate them and improve efficiencies in health care systems.”

TKI costs

Bernardo H.L. Goulart, MD, MS
Bernardo H.L. Goulart

Higher out-of-pocket costs for TKI inhibitors lead to fewer prescriptions, shorter duration of TKI therapy and ultimately inferior survival among patients with advanced EGFR- and ALK-positive NSCLC.

“Patients paying the highest out-of-pocket costs for TKIs have a greater risk [for] death,” Bernardo H.L. Goulart, MD, MS, researcher and medical oncologist at Fred Hutchinson Cancer Research Center, said in a press release. “If we can confirm the results with a larger nationwide sample, the findings help to make the case for a review of Medicare coverage for these effective medications.”

Goulart and colleagues analyzed 106 patients (median age, 69 years; 67% women; 73% white; 35% Medicare enrollees) with stage IV NSCLC diagnosed between 2010 and 2016. Eighty-five percent of patients harbored EGFR mutations.

Eligible patients had survived at least 3 months following the initiation of TKI therapy and had been enrolled in their insurance for least 12 months after diagnosis.

Researchers derived patient data from the Washington State SEER registry and linked registry records to commercial and Medicare claims to assess the association between high out-of-pocket costs for TKIs and clinical outcomes. They calculated out-of-pocket TKI costs by subtracting the amount paid from the amount allowed in pharmacy claims, and then categorized patients into quartiles for the first 3 months of TKI therapy based on costs.

Researchers calculated 3-month survival outcomes using multivariate Cox regression models based on monthly out-of-pocket costs for the first 3 months of TKI therapy for those in quartiles (Q) 1 through 3 vs. 4. They also used t-tests to compare medication possession ratio (MPR) and duration of treatment for the first TKI between the quartiles.

Results showed that monthly out-of-pocket costs for TKIs at 3 months were $0 for those in Q1, $1,432 for Q2, $1,798 for Q3 and $2,888 for Q4.

Mean MPR was 1.2 for Q1-3 vs. 1.06 for Q4 (P = .02). Patients in the first three quartiles also had longer median duration of treatment at 8 months vs. 4 months for those in Q4 (P < .01).

Median OS was 22 months for patients in Q1-3 vs. 9 months for Q4, equating to an HR for death of 1.76 (95% CI, 1.05-2.94) for patients in Q4 after adjustment for age, sex, insurance, mutation, income, chemotherapy use, and time to TKI start.

Prior authorizations

Researchers from Seattle Cancer Care Alliance found that nearly 95% of prior authorizations for imaging studies were immediately approved or approved shortly after gathering additional information, indicating the authorization process does not add value to care.

“[Although] prior authorizations are intended to ensure medical necessity, these additional requirements can add to administrative burden,” Mallika Sharma, MPH, a quality and value analyst at Seattle Cancer Care Alliance, said in a press release. “In some cases, the process can even cause significant delays for patients, increasing their anxiety and diminishing quality of life.”

Sharma and colleagues analyzed imaging requests at Seattle Cancer Care Alliance and found that 94.8% of prior authorizations were approved instantly or right after receiving more documentation, 2.15% of requests were approved after a peer-to-peer review, and only 3% of requests were denied. Reasons for denials included that PET/CT and CT CAP were ordered in combination, or PET/CT was ordered without clear justification.

Based on these findings, all ordering providers underwent training on the National Comprehensive Cancer Network guidelines for ordering imaging tests. After all providers completed this training, Seattle Cancer Care Alliance agreed with willing insurance companies to eliminate prior authorizations for all imaging except PET and PET/CT.

“[Seattle Cancer Care Alliance] uses an in-house tool to support clinical decision-making,” Tracy Wong, MBA, agency owner of Insurance Solutions LLC, said in a press release. “However, most electronic health records have the capability to embed clinical decision support that aligns with payers’ medical coverage policies, making this a relatively simple and scalable way to speed and improve care. This is what payers are asking for: the ability for providers to access the most up-to-date, evidence-based practice guidelines in real time.” – by John DeRosier

References:

Goulart BHL, et al. Abstract 3. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.

Sharma M, et al. Abstract 9. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.

Disclosures: Goulart reports travel expenses from Flatiron Health. Sharma and Wong report no relevant financial disclosures. Please see the abstracts for all other authors’ relevant financial disclosures. Agarwal reports consultant/advisory roles with, or research funding paid to his institution from, Active Biotech, Amgen, AstraZeneca, Bavarian Nordic, Bayer, BN ImmunoTherapuetics, Bristol-Myers Squibb, Calithera Biosciences, Celldex, Clovis Oncology, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation One, Genentech/Roche, GlaxoSmithKline, Immunomedics, Janssen, Medivation/Astellas, Merck, Nektar, Newlink Genetics, Novartis, Pfizer, Pharmacyclics, Promethus, Rexahn Pharmaceuticals, Sanofi, Takeda and TRACON Pharma. 

Neeraj Agarwal

High drug costs and regulations requiring prior authorization of treatment plans are barriers to cancer treatment that can affect clinical outcomes for patients, according to results of two studies scheduled for presentation at Quality Care Symposium.

The studies independently examined high out-of-pocket costs of oral tyrosine kinase inhibitors for patients with non-small cell lung cancer and prior authorizations for imaging that may delay and inhibit cancer care.

“The high costs of cancer care have many facets that often result in barriers to accessing timely and consistent care,” Neeraj Agarwal, MD, ASCO expert who was not involved with either study, said in a press release. “High out-of-pocket drug costs, shown here with oral anticancer drugs, are associated with a lower number of prescriptions, shorter duration of therapy, and inferior cancer-associated outcomes. Another aspect is the administrative burden seen in one study that finds a vast majority of prior authorizations are redundant, and a close collaboration between hospitals and insurers can help eliminate them and improve efficiencies in health care systems.”

TKI costs

Bernardo H.L. Goulart, MD, MS
Bernardo H.L. Goulart

Higher out-of-pocket costs for TKI inhibitors lead to fewer prescriptions, shorter duration of TKI therapy and ultimately inferior survival among patients with advanced EGFR- and ALK-positive NSCLC.

“Patients paying the highest out-of-pocket costs for TKIs have a greater risk [for] death,” Bernardo H.L. Goulart, MD, MS, researcher and medical oncologist at Fred Hutchinson Cancer Research Center, said in a press release. “If we can confirm the results with a larger nationwide sample, the findings help to make the case for a review of Medicare coverage for these effective medications.”

Goulart and colleagues analyzed 106 patients (median age, 69 years; 67% women; 73% white; 35% Medicare enrollees) with stage IV NSCLC diagnosed between 2010 and 2016. Eighty-five percent of patients harbored EGFR mutations.

Eligible patients had survived at least 3 months following the initiation of TKI therapy and had been enrolled in their insurance for least 12 months after diagnosis.

Researchers derived patient data from the Washington State SEER registry and linked registry records to commercial and Medicare claims to assess the association between high out-of-pocket costs for TKIs and clinical outcomes. They calculated out-of-pocket TKI costs by subtracting the amount paid from the amount allowed in pharmacy claims, and then categorized patients into quartiles for the first 3 months of TKI therapy based on costs.

Researchers calculated 3-month survival outcomes using multivariate Cox regression models based on monthly out-of-pocket costs for the first 3 months of TKI therapy for those in quartiles (Q) 1 through 3 vs. 4. They also used t-tests to compare medication possession ratio (MPR) and duration of treatment for the first TKI between the quartiles.

PAGE BREAK

Results showed that monthly out-of-pocket costs for TKIs at 3 months were $0 for those in Q1, $1,432 for Q2, $1,798 for Q3 and $2,888 for Q4.

Mean MPR was 1.2 for Q1-3 vs. 1.06 for Q4 (P = .02). Patients in the first three quartiles also had longer median duration of treatment at 8 months vs. 4 months for those in Q4 (P < .01).

Median OS was 22 months for patients in Q1-3 vs. 9 months for Q4, equating to an HR for death of 1.76 (95% CI, 1.05-2.94) for patients in Q4 after adjustment for age, sex, insurance, mutation, income, chemotherapy use, and time to TKI start.

Prior authorizations

Researchers from Seattle Cancer Care Alliance found that nearly 95% of prior authorizations for imaging studies were immediately approved or approved shortly after gathering additional information, indicating the authorization process does not add value to care.

“[Although] prior authorizations are intended to ensure medical necessity, these additional requirements can add to administrative burden,” Mallika Sharma, MPH, a quality and value analyst at Seattle Cancer Care Alliance, said in a press release. “In some cases, the process can even cause significant delays for patients, increasing their anxiety and diminishing quality of life.”

Sharma and colleagues analyzed imaging requests at Seattle Cancer Care Alliance and found that 94.8% of prior authorizations were approved instantly or right after receiving more documentation, 2.15% of requests were approved after a peer-to-peer review, and only 3% of requests were denied. Reasons for denials included that PET/CT and CT CAP were ordered in combination, or PET/CT was ordered without clear justification.

Based on these findings, all ordering providers underwent training on the National Comprehensive Cancer Network guidelines for ordering imaging tests. After all providers completed this training, Seattle Cancer Care Alliance agreed with willing insurance companies to eliminate prior authorizations for all imaging except PET and PET/CT.

“[Seattle Cancer Care Alliance] uses an in-house tool to support clinical decision-making,” Tracy Wong, MBA, agency owner of Insurance Solutions LLC, said in a press release. “However, most electronic health records have the capability to embed clinical decision support that aligns with payers’ medical coverage policies, making this a relatively simple and scalable way to speed and improve care. This is what payers are asking for: the ability for providers to access the most up-to-date, evidence-based practice guidelines in real time.” – by John DeRosier

References:

Goulart BHL, et al. Abstract 3. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.

Sharma M, et al. Abstract 9. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.

Disclosures: Goulart reports travel expenses from Flatiron Health. Sharma and Wong report no relevant financial disclosures. Please see the abstracts for all other authors’ relevant financial disclosures. Agarwal reports consultant/advisory roles with, or research funding paid to his institution from, Active Biotech, Amgen, AstraZeneca, Bavarian Nordic, Bayer, BN ImmunoTherapuetics, Bristol-Myers Squibb, Calithera Biosciences, Celldex, Clovis Oncology, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation One, Genentech/Roche, GlaxoSmithKline, Immunomedics, Janssen, Medivation/Astellas, Merck, Nektar, Newlink Genetics, Novartis, Pfizer, Pharmacyclics, Promethus, Rexahn Pharmaceuticals, Sanofi, Takeda and TRACON Pharma.