Impact of Sofosbuvir on Utilization and Expenditure of Hepatitis C Medications  in a Medicaid Population

K. Prasla, PharmD, MS, BCPS; K. Lockhart, MA; C. Pigg, BSPharm, MHA, FAMCPMagellan Rx Management • Glen Allen, VA

AMCP Nexus 2014 • Boston, MA

BACKGROUND METHODS

• Hepatitis C affects approximately 3.2 million people in the United States.

• It is estimated that the prevalence of Hepatitis C is doubled in the Medicaid population versus the commercial population.

• The approval of sofosbuvir (Sovaldi ) in December 2013 for the treatment of chronic Hepatitis C offers improved efficacy and tolerability over other Hepatitis C regimens at a significantly greater cost.

– Clinical trials have shown Sofosbuvir to have a cure rate of about 89 - 95%.

– The cost of sofosbuvir itself is around $84,000 for a 12-week course; however, while taken in combination as part of the treatment regimen, the cost can be approximately $95,000 - $170,000.

• The anticipation of greater efficacious therapies has led physicians to defer treatment for some patients, a phenomenon called “warehousing.”

OBJECTIVE

• To evaluate the impact of sofosbuvir on utilization and expenditure, along with pattern of Hepatitis C treatment regimens in a Medicaid population.

• A large state government database of pharmacy claims (greater than 1M lives) was used to identify Hepatitis C patients based on claims for Hepatitis C therapies (i.e. peg interferon, ribavirin, telaprevir, boceprevir, sofosbuvir, and simeprevir) between January 1, 2013 and June 30, 2014.

• Utilization, expenditure, and Hepatitis C prescribing patterns were evaluated for this population before and after approval of sofosbuvir.

– The pre-period for direct comparison was June 1 to November 30, 2013.

– The post-period for direct comparison was December 1, 2013 to May 31, 2014.

– Claims volume and plan cost was used to evaluate utilization and expenditure, either as percent of total drug cost or per member per month (PMPM) cost.

• To assess duration of sofosbuvir based regimens, Hepatitis C patients continuously enrolled between December 1, 2013 and June 30, 2014 were evaluated.

• Descriptive statistics were used to assess results.

RESULTS

DISCUSSION

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LIMITATIONS

• This study was conducted with data from a single state Medicaid population, thus the generalizability could be limited.

• The study only considered general overall utilization and economic trends following market entry of sofosbuvir.

• No clinical outcomes were considered to assess the true economic impact of sofosbuvir.

Figure 3. Hepatitis C Regimens Post Sofosbuvir Market Entry

CONCLUSION

REFERENCES

1. Milliman. Health Care Reform and Hepatitis C: A Convergence of Risk and Opportunity. 10 December 2013.

2. Lawitz, E., Mangia, A., Wyles, D., et al. Sofosbuvir for previously untreated chronic Hepatitis C infection. N Engl J Med. 2013;368:1878-87.

3. First Databank.

4. Infectious Disease Society of America. Recommendations for testing, managing, and treating Hepatitis C. Aug 2014.

DISCLOSURES

• This research was conducted by Magellan Rx Management, Glen Allen, VA, without external funding.

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• Sofosbuvir has shifted the paradigm for the treatment of chronic Hepatitis C, with 90% of new patients starting on a sofosbuvir-based regimen.

• This change in prescribing behavior, along with a greater number of Hepatitis C patients’ now receiving therapy, has significantly impacted overall pharmacy expenditure.

• Patients who were previously “warehoused” most likely contributed to the significant increase in the number of patients starting Hepatitis C therapy.

– It is unsure what the continued impact on utilization and expenditure will be as other drugs in the Hepatitis C pipeline, considered to be equally efficacious and safe, are approved in the upcoming months.

• Further research is needed to assess the real-world impact on sustained viral response rates and clinical outcomes, to determine the overall cost- effectiveness of sofosbuvir.

• Following entry of sofosbuvir to the market, costs associated with Hepatitis C therapies increased from approximately 2.2% of total pharmacy costs between January 2013 and November 2013 to about 5.5% in the 7 months after December 2013, while Hepatitis C PMPM went from $1.17 to $3.10. (Figure 1)

– Following a peak of about 9% and a PMPM of $5.50 in March 2014, Hepatitis C costs as a percentage of total pharmacy costs and PMPM have declined since. (Figure 1)

• The number of patients starting on a Hepatitis C regimen went from 210 to 293 (39% increase) from September to November 2013 and December 2013 to February 2014, respectively; cost per patient increased from $52,111 to $79,427 (52% increase) from September to November 2013 and December 2013 to February 2014, respectively. (Figure 2)

• Following December 2013, 90% of the Hepatitis C regimens were sofosbuvir based, with 53% of those being in combination with peg-interferon and ribavirin. (Figure 3)

– Sofosbuvir accounts for approximately 90% of the overall Hepatitis C regimen cost.

• Of the sofosbuvir-based regimens, 68% had a treatment duration of 12 weeks. (Figure 4)

– All patients starting a 12-week or 24-week sofosbuvir-based regimen completed the full course of therapy, as determined by having no claims for subsequent Hepatitis C therapy.

Figure 1. Hepatitis C Expenditure

PMPM % Total Spend

10%

8%

6%

4%

2%

0%

Jan.

13

Perc

ent o

f Tot

al D

rug

Spen

d

Feb.

13

Mar

. 13

Apr.

13

May

13

Jun.

13

Jul.

13

Aug.

13

Sep.

13

Oct

. 13

Nov

. 13

Dec

. 13

Jan.

14

Feb.

14

Mar

. 14

Apr.

14

May

14

Jun.

14

$6

$4

$5

$3

$2

$1

$0

PMPM

Figure 2. Hepatitis C Patients and Expenditure

350

250

300

200

150

100

50

0

Pati

ents

June 2013to Aug. 2013

Sept. 2013to Nov. 2013

Dec. 2013to Feb. 2014

Mar. 2014to May 2014

$100K

$60K

$80K

$40K

$20K

$0

Cost/Patient Patients

$48,908

232

$52,111

$79,427

$86,587

210

293302

100%

80%

60%

40%

20%

0%

10.1%

53.0%

36.0%

Sofosbuvir + Ribavirin

Sofosbuvir + Ribavirin + Peg-interferon

Sofosbuvir + Simeprevir

Other

.9%

Figure 4. Sofosbuvir-Based Regimen

80

60

40

20

04 12 20

7%4%

68%

5%

10%

7%

Treatment Duration (Weeks)

% o

f Pat

ient

s

8 16 24