OIA Response: Erlotinib and other medicines data

Request for information dated 4 February 2019 on erlotinib, obinutuzumab, pertuzumab, pirfenidone, rutixmab, trastuzumab, melanoma, multiple sclerosis and gefitinib.

01 April 2019

[Name and contact details redacted]

Dear [Name redacted]

REQUEST FOR INFORMATION

I refer to your request dated 04 February 2019 under the Official Information Act (OIA) and my letter to you dated 05 March 2019, which notified you of an extension of the time to make a decision on your request.

You requested information on erlotinib, obinutuzumab, pertuzumab, pirfenidone, rituximab, trastuzumab, melanoma, multiple sclerosis and gefitinib.

The information you have requested is attached to this letter, subject to the provisions stated below.

Where the request for information is at DHB level, PHARMAC does not hold this information and therefore this part of your request is refused under section 18(g) of the OIA as the information is not held by PHARMAC, and we have no reason to believe it is held by another agency in that form.

Please note that PHARMAC does not hold any data on prescriptions which did not result in a dispensing. A prescription (or script) is counted as having no repeats (stat dispensing) or is the first repeat of a number of dispensings. It is important to note that PHARMAC does not hold any data on prescriptions which did not result in a dispensing. The information has been provided per calendar year.

The following requests for information would require PHARMAC to create new information, which is not classified as official information under the OIA and in this respect this part of your request is refused under section 18(g) of the OIA as the information is not held by PHARMAC, and we have no reason to believe it is held by another agency in that form.

  • Pirfenidone: Questions 7 and 8
  • Rituximab: Question 6
  • Multiple Sclerosis: Questions 3 and 5

In respect of rituximab: Question 7, PHARMAC does not hold this information at this time but will provide it without undue delay and therefore this part of your request is refused at this time under section 18(g) of the OIA as the information is not held by PHARMAC, and we have no reason to believe it is held by another agency in that form.

Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision

We trust that the provision of this information answers your queries, if you have any further questions please feel free to contact us again.

Yours sincerely

[Alison Hill's signature]

Alison Hill
Director, Engagement and Implementation

Official Information Request data: [Name redacted]

Erlonitinib

  1. How many unique patients received erlotinib in total in the following years? 2016, 2017, 2018

Calendar year

Number of patients

2016

149

2017

166

2018

175

2. How many patients, dispensings and prescriptions of erlotinib were there in each month of the following years? 2016, 2017, 2018

Month

Number of patients

Number of dispensings

Number of scripts

1/01/2016

61

76

34

1/02/2016

60

72

36

1/03/2016

62

75

29

1/04/2016

57

67

33

1/05/2016

64

81

41

1/06/2016

62

69

37

1/07/2016

60

71

33

1/08/2016

63

71

41

1/09/2016

58

64

28

1/10/2016

63

70

35

1/11/2016

64

82

50

1/12/2016

65

81

35

1/01/2017

59

69

36

1/02/2017

69

83

49

1/03/2017

75

92

42

1/04/2017

72

88

48

1/05/2017

76

92

50

1/06/2017

65

77

30

1/07/2017

84

108

63

1/08/2017

79

93

50

1/09/2017

74

89

52

1/10/2017

82

102

43

1/11/2017

81

90

47

1/12/2017

78

96

38

1/01/2018

67

84

40

1/02/2018

69

81

33

1/03/2018

69

81

46

1/04/2018

71

84

44

1/05/2018

83

99

46

1/06/2018

70

79

38

1/07/2018

80

97

50

1/08/2018

81

98

46

1/09/2018

78

87

38

1/10/2018

83

101

55

1/11/2018

96

114

59

1/12/2018

87

108

53

3. How many new patients (patients starting treatment) received erlotinib in each month of the following years? 2016, 2017, 2018

Month

Number of new patients

1/01/2016

6

1/02/2016

5

1/03/2016

8

1/04/2016

4

1/05/2016

8

1/06/2016

9

1/07/2016

5

1/08/2016

6

1/09/2016

6

1/10/2016

7

1/11/2016

10

1/12/2016

8

1/01/2017

3

1/02/2017

15

1/03/2017

8

1/04/2017

6

1/05/2017

6

1/06/2017

5

1/07/2017

10

1/08/2017

7

1/09/2017

6

1/10/2017

8

1/11/2017

11

1/12/2017

3

1/01/2018

6

1/02/2018

3

1/03/2018

14

1/04/2018

7

1/05/2018

11

1/06/2018

7

1/07/2018

7

1/08/2018

10

1/09/2018

6

1/10/2018

5

1/11/2018

12

1/12/2018

10

Obinutuzumab

  1. How many new patients (patients starting treatment) received treatment with obinutuzumab reported by individual month (month of first dispensing) for 2018?

Month

Number of patients

1/01/2018

5

1/02/2018

6

1/03/2018

6

1/04/2018

3

1/05/2018

11

1/06/2018

2

1/07/2018

1

1/08/2018

5

1/09/2018

3

1/10/2018

6

1/11/2018

1

1/12/2018

2

  1. How many patients have had more than 1 dispensing of obinutuzumab reported by individual month for 2018?

Month

Number of patients

1/01/2018

7

1/02/2018

8

1/03/2018

11

1/04/2018

6

1/05/2018

15

1/06/2018

6

1/07/2018

7

1/08/2018

6

1/09/2018

4

1/10/2018

9

1/11/2018

5

1/12/2018

3

Pertuzumab

  1. How many new patients (patients starting treatment) were approved for mBC treatment with Pertuzumab under Special Authority in 2018? Reported by DHB of dispensing and individual month (month of first dispensing).

Month

Number of patients

1/01/2018

3

1/02/2018

4

1/03/2018

4

1/04/2018

4

1/05/2018

10

1/06/2018

7

1/07/2018

9

1/08/2018

11

1/09/2018

12

1/10/2018

8

1/11/2018

8

1/12/2018

6

Pirfenidone

  1. In total, how many different patients received pirfenidone across 2017 and 2018 combined?

230

  1. How many patients received pirfenidone in the following years? 2017, 2018

Calendar year

Number of patients

2017

132

2018

165

  1. How many new patients started treatment each month in 2017 and 2018?

Month

Number of new patients

1/01/2017

19

1/02/2017

19

1/03/2017

16

1/04/2017

11

1/05/2017

11

1/06/2017

10

1/07/2017

11

1/08/2017

7

1/09/2017

2

1/10/2017

8

1/11/2017

12

1/12/2017

6

1/01/2018

7

1/02/2018

12

1/03/2018

9

1/04/2018

8

1/05/2018

11

1/06/2018

3

1/07/2018

11

1/08/2018

7

1/09/2018

9

1/10/2018

6

1/11/2018

8

1/12/2018

7

  1. On average, how many units was each patient dispensed at initiation?

Calendar year

Number of units

2017

272

2018

267

  1. On average, how many units was each patient dispensed in repeat dispensing?

Calendar year

Number of units

2017

256

2018

255

  1. How many repeat dispensings were there each month in 2017 and 2018 (not first dispensings)

Month

Number of dispensings

1/01/2017

2

1/02/2017

16

1/03/2017

39

1/04/2017

42

1/05/2017

63

1/06/2017

57

1/07/2017

52

1/08/2017

70

1/09/2017

60

1/10/2017

58

1/11/2017

62

1/12/2017

63

1/01/2018

60

1/02/2018

45

1/03/2018

61

1/04/2018

70

1/05/2018

70

1/06/2018

83

1/07/2018

79

1/08/2018

84

1/09/2018

78

1/10/2018

92

1/11/2018

79

1/12/2018

83

  1. How many patients stopped treatment in 2017 and 2018 (i.e. did not have a repeat dispensing)? Stopping treatment is defined as having received no dispensings for a minimum of 3 months.

Please refer to PHARMAC’s response in the covering letter.

  1. On average, how many units (tablets) were those patients dispensed before they stopped treatment?

Please refer to PHARMAC’s response in the covering letter.

  1. How many patients have received only 1 dispensing of pirfenidone in each month of 2017 and 2018?

Month

Number of patients

1/01/2017

18

1/02/2017

29

1/03/2017

40

1/04/2017

41

1/05/2017

53

1/06/2017

51

1/07/2017

44

1/08/2017

59

1/09/2017

52

1/10/2017

46

1/11/2017

54

1/12/2017

52

1/01/2018

47

1/02/2018

51

1/03/2018

52

1/04/2018

59

1/05/2018

59

1/06/2018

62

1/07/2018

59

1/08/2018

58

1/09/2018

65

1/10/2018

65

1/11/2018

62

1/12/2018

63

10. How many pirfenidone scripts, dispensings, and units (tablets) were there in each month of 2017 and 2018?

Month

Number of units dispensed

Number of dispensings

Number of scripts

1/01/2017

5940

21

19

1/02/2017

9450

35

20

1/03/2017

14850

55

20

1/04/2017

11928

53

23

1/05/2017

19188

74

37

1/06/2017

18072

67

24

1/07/2017

15318

63

26

1/08/2017

20331

77

34

1/09/2017

16074

62

25

1/10/2017

16208

66

25

1/11/2017

19209

74

32

1/12/2017

17469

69

30

1/01/2018

17499

67

27

1/02/2018

13797

57

26

1/03/2018

19071

70

31

1/04/2018

19835

78

37

1/05/2018

20219

81

32

1/06/2018

21369

86

33

1/07/2018

22354

90

44

1/08/2018

22657

91

30

1/09/2018

23496

87

33

1/10/2018

25674

98

42

1/11/2018

21574

87

37

1/12/2018

21229

90

33


Rituximab

  1. How many initial Post-transplant applications were approved under Special Authority in 2018?

21

  1. How many initial Indolent, low-grade lymphomas applications were approved under Special Authority in 2018?

337

  1. How many Special Authority applications were approved for indolent low grade NHL with relapsed disease following prior chemotherapy?

139

  1. How many Special Authority applications were approved for low grade lymphoma requiring first-line systemic chemotherapy?

198

  1. How many initial Aggressive CD20 positive NHL applications were approved under Special Authority?

413

  1. How many Special Authority applications were approved for naïve aggressive CD20 positive NHL?

394

  1. How many Special Authority applications were approved for aggressive CD20 positive NHL with relapsed disease following prior chemotherapy?

19

  1. How many initial Special Authority Chronic Lymphocytic Leukaemia applications were approved under Special Authority?

80

  1. How many were approved where the patient is chemotherapy treatment naïve?

73

  1. b. How many were approved where the patient's disease has relapsed?

7

  1. How many renewals were there for:
    1. Post-transplant applications approved in 2018.

0

  1. Indolent, low grade lymphomas applications approved in 2018.

48

  1. Aggressive CD20 positive NHL applications approved in 2018.

16

  1. Chronic Lymphocytic Leukaemia applications approved in 2018.

0

  1. How many patients approved for Chronic Lymphocytic Leukaemia under Special Authority for bendamustine (Special Authority 1667) were receiving treatment in combination with rituximab in 2018?

Please refer to PHARMAC’s response in the covering letter.

  1. How many vials of rituximab were dispensed through the HML reported by DHB, formulation (100mg vials and 500mg vials), and month.

Please refer to PHARMAC’s response in the covering letter.

  1. How many Special Authority applications were there for initial treatment of Rheumatoid arthritis in 2018?

0

  1. How many of Special Authority applications were there for the re treatment of Rheumatoid arthritis in 2018?

0

Trastuzumab

Note: We have defined ‘new patients’ as ‘initial approvals’.

Month

1. How many new patients were approved for mBC treatment under Special Authority in 2018 reported by DHB of dispensing and individual month where trastuzumab will not be given in combination with pertzumab?

2. How many new patients were approved for mBC treatment under Special Authority in 2018 reported by DHB of dispensing and individual month where trastuzumab is to be administered in combination with pertzumab?

3. How many renewals were approved for mBC treatment under Special Authority in 2018? Reported by DHB of dispensing and individual month.

4. How many new patients were approved for eBC treatment under Special Authority in 2018, reported by DHB of dispensing and individual month.

1/01/2018

1

4

18

30

1/02/2018

0

4

11

32

1/03/2018

1

4

6

32

1/04/2018

0

2

17

40

1/05/2018

1

8

20

32

1/06/2018

1

4

13

28

1/07/2018

2

10

9

33

1/08/2018

2

8

13

28

1/09/2018

2

11

4

44

1/10/2018

0

7

15

25

1/11/2018

4

6

13

33

1/12/2018

1

6

6

30

5. How many Special Authority approvals were there for ebc? Reported by DHB of dispensing and individual month in 2018, for each of the following Special Authority criteria?

Month

a. 9 weeks concurrent treatment with adjuvant chemotherapy is planned

b. 12 months concurrent treatment with adjuvant chemotherapy is planned

c. 12 months sequential treatment following adjuvant chemotherapy is planned

d. 12 months treatment with neoadjuvant and adjuvant chemotherapy is planned

e. Other treatment regimen, in association with adjuvant chemotherapy, is planned

1/01/2018

0

21

3

4

2

1/02/2018

1

27

2

1

1

1/03/2018

1

27

1

5

2

1/04/2018

1

26

3

8

2

1/05/2018

1

26

2

2

1

1/06/2018

0

18

1

4

6

1/07/2018

1

23

4

5

0

1/08/2018

1

19

2

5

1

1/09/2018

1

31

2

8

2

1/10/2018

0

15

4

3

3

1/11/2018

0

18

7

7

2

1/12/2018

1

23

2

4

0

Month

6. How many eBC renewals were approved for treatment under Special Authority in 2018 reported by DHB of dispensing and individual month where trastuzumab will not be given in combination with pertuzumab?

7. How many eBC renewals were approved for treatment under Special Authority in 2018 reported by DHB of dispensing and individual month where trastuzumab is to be administered in combination with pertuzumab?

1/01/2018

0

0

1/02/2018

0

0

1/03/2018

0

0

1/04/2018

0

0

1/05/2018

0

2

1/06/2018

0

1

1/07/2018

0

0

1/08/2018

0

1

1/09/2018

0

0

1/10/2018

0

0

1/11/2018

0

0

1/12/2018

0

1

Melanoma

Note: We have defined ‘new patients’ as ‘initial approvals’.

  1. How many unique patients have been approved under Special Authority forms 1656 and 1657 the following years? 2016, 2017, 2018

From further discussion with requestor:

a. The total number of SA approvals for Nivolumab and Pembrolizumab for those years (all SA forms applicable).

Calendar Year

Nivolumab (ALL SA)

Pembrolizumab (ALL SA)

2016

84

191

2017

63

608

2018

53

709

b. The total number of SA approvals specifically for SA1656 and SA1657.

Calendar Year

Nivolumab  (SA1656)

Pembrolizumab (SA1657)

2016

0

0

2017

29

311

2018

53

709

c. The total unique patients who received a dispensing of Nivolumab and Pembrolizumab for those years (all SA forms applicable).

Chemical name

Calendar year

Total patients

Nivolumab

2016

52

Nivolumab

2017

33

Nivolumab

2018

29

Pembrolizumab

2016

166

Pembrolizumab

2017

386

Pembrolizumab

2018

442

  1. How many patients, dispensings, and prescriptions were there under Special Authority forms 1656 and 1657 in each month of the following years? 2016, 2017, 2018

Note: data provided for question 2 is for all Special Authority forms related to Nivolumab and Pembrolizumab.

Chemical name

Month

Number of patients

Number of dispensings

Number of scripts

Nivolumab

1/07/2016

31

74

74

1/08/2016

44

122

122

1/09/2016

45

126

126

1/10/2016

34

85

85

1/11/2016

28

72

72

1/12/2016

27

77

77

1/01/2017

25

65

65

1/02/2017

28

73

73

1/03/2017

26

71

71

1/04/2017

24

55

55

1/05/2017

27

70

70

1/06/2017

25

70

70

1/07/2017

25

65

65

1/08/2017

24

70

70

1/09/2017

20

50

50

1/10/2017

22

55

55

1/11/2017

20

55

55

1/12/2017

24

68

68

1/01/2018

23

58

58

1/02/2018

22

54

54

1/03/2018

24

66

66

1/04/2018

23

56

56

1/05/2018

23

62

62

1/06/2018

21

52

52

1/07/2018

20

50

50

1/08/2018

18

47

47

1/09/2018

18

43

43

1/10/2018

15

39

39

1/11/2018

15

42

42

1/12/2018

15

38

38

Pembrolizumab

1/07/2016

77

97

97

1/08/2016

98

119

119

1/09/2016

117

168

168

1/10/2016

130

170

170

1/11/2016

140

192

192

1/12/2016

141

191

191

1/01/2017

163

251

251

1/02/2017

159

218

218

1/03/2017

156

223

223

1/04/2017

169

255

255

1/05/2017

165

220

220

1/06/2017

165

245

245

1/07/2017

169

235

235

1/08/2017

177

253

253

1/09/2017

187

278

278

1/10/2017

177

237

237

1/11/2017

194

287

287

1/12/2017

195

260

260

1/01/2018

202

296

296

1/02/2018

201

273

273

1/03/2018

214

319

319

1/04/2018

209

290

290

1/05/2018

213

304

304

1/06/2018

235

368

368

1/07/2018

251

337

337

1/08/2018

252

368

368

1/09/2018

254

367

367

1/10/2018

245

339

339

1/11/2018

77

97

97

1/12/2018

98

119

119

  1. How many new patients (patients starting treatment) were there under Special Authority forms 1656 and 1657 in each month of the following years? 2016, 2017, 2018

Note: data provided for question 3 is for all Special Authority forms related to Nivolumab and Pembrolizumab.

Month

Nivolumab

Pembrolizumab

1/07/2016

30

76

1/08/2016

16

31

1/09/2016

4

24

1/10/2016

1

35

1/11/2016

1

22

1/12/2016

0

20

1/01/2017

0

33

1/02/2017

3

26

1/03/2017

0

15

1/04/2017

0

21

1/05/2017

1

17

1/06/2017

0

20

1/07/2017

1

22

1/08/2017

1

25

1/09/2017

1

25

1/10/2017

0

18

1/11/2017

0

25

1/12/2017

1

17

1/01/2018

0

22

1/02/2018

0

18

1/03/2018

1

23

1/04/2018

1

17

1/05/2018

1

24

1/06/2018

1

25

1/07/2018

0

29

1/08/2018

0

25

1/09/2018

1

25

1/10/2018

0

15

1/11/2018

1

76

1/12/2018

0

31

Multiple Sclerosis

Note: We have defined ‘new patients’ as ‘initial approvals’.

  1. How many patients have been approved under Special Authority forms 1559, 1560, 1562, 1563, 1564 for MS treatment? In 2016, 2017, 2018

Calendar year

Number of patients

2016

878

2017

1144

2018

1323

  1. How many new patients have been approved under Special Authority forms 1559, 1560, 1562, 1563, 1564 each month from 2016-2018?

Month

Number of patients

1/01/2016

0

1/02/2016

81

1/03/2016

78

1/04/2016

78

1/05/2016

76

1/06/2016

115

1/07/2016

52

1/08/2016

113

1/09/2016

58

1/10/2016

61

1/11/2016

102

1/12/2016

64

1/01/2017

50

1/02/2017

112

1/03/2017

69

1/04/2017

94

1/05/2017

130

1/06/2017

67

1/07/2017

90

1/08/2017

125

1/09/2017

135

1/10/2017

87

1/11/2017

84

1/12/2017

101

1/01/2018

77

1/02/2018

117

1/03/2018

117

1/04/2018

109

1/05/2018

130

1/06/2018

97

1/07/2018

86

1/08/2018

162

1/09/2018

101

1/10/2018

104

1/11/2018

107

1/12/2018

116

  1. How many patients approved under Special Authority forms 1559, 1560, 1562, 1563, 1564 have switched treatment to a new MS treatment once, twice, or three or more times?

Please refer to PHARMAC’s response in the covering letter.

5. For patients who have switched treatment once, on average how long are they on their first MS treatment?

Please refer to PHARMAC’s response in the covering letter.

Gefitinib

  1. How many unique patients received gefitinib in total in the following years? 2016, 2017, 2018

Calendar year

Total unique patients

2016

94

2017

97

2018

98

2. How many patients, dispensing and prescriptions of gefitinib were there in each month of the following years? 2016, 2017, 2018

Month

Number of patients

Number units dispensed

Number of dispensings

Number of scripts

1/01/2016

47

1831

61

19

1/02/2016

40

1441

48

23

1/03/2016

41

1429

45

19

1/04/2016

41

1616

50

18

1/05/2016

42

1550

50

25

1/06/2016

40

1496

49

24

1/07/2016

37

1466

45

17

1/08/2016

44

1764

49

25

1/09/2016

41

1610

48

22

1/10/2016

47

1599

51

18

1/11/2016

46

1584

51

26

1/12/2016

48

1706

52

22

1/01/2017

41

1376

46

13

1/02/2017

43

1612

50

27

1/03/2017

46

1672

53

23

1/04/2017

48

1651

53

25

1/05/2017

49

1886

60

26

1/06/2017

44

1554

52

20

1/07/2017

44

1586

50

21

1/08/2017

50

1978

62

29

1/09/2017

48

1595

52

24

1/10/2017

47

1753

55

19

1/11/2017

47

1800

54

23

1/12/2017

46

1590

50

24

1/01/2018

46

1590

51

22

1/02/2018

45

1650

51

17

1/03/2018

52

1845

60

27

1/04/2018

52

1961

58

25

1/05/2018

48

1768

56

24

1/06/2018

45

1663

50

26

1/07/2018

55

2024

65

30

1/08/2018

46

1740

56

25

1/09/2018

43

1575

48

27

1/10/2018

51

1875

58

25

1/11/2018

49

1950

56

22

1/12/2018

43

1466

47

26

3. How many new patients (patients starting treatment) received gefitinib in each month of the following years? 2016, 2017, 2018

Month

Number of new patients

1/01/2016

4

1/02/2016

3

1/03/2016

3

1/04/2016

4

1/05/2016

2

1/06/2016

1

1/07/2016

6

1/08/2016

4

1/09/2016

4

1/10/2016

3

1/11/2016

7

1/12/2016

5

1/01/2017

3

1/02/2017

6

1/03/2017

7

1/04/2017

4

1/05/2017

3

1/06/2017

2

1/07/2017

7

1/08/2017

2

1/09/2017

5

1/10/2017

5

1/11/2017

3

1/12/2017

4

1/01/2018

3

1/02/2018

4

1/03/2018

3

1/04/2018

2

1/05/2018

4

1/06/2018

4

1/07/2018

3

1/08/2018

5

1/09/2018

4

1/10/2018

4

1/11/2018

7

1/12/2018

4